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 .
Claim Rejections - 35 USC § 101
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 1-8, 13-15 and 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the mental concept of receiving data related to a target and location of a lead and stimulation criterion, identifying a value of a cost parameter that meet the stimulation criterion, and providing/transmitting the value of the cost parameter to a user or another system. This judicial exception is not integrated into a practical application because the combination of additional elements fails to integrate the judicial exception into a practical application. The generically recited computer elements (e.g. claim 13, a processor with a lead and control unit; claim 17, non-transitory computer readable medium; claim 1 is not connected to any element; etc.) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. In addition, the use of the lead and control unit are merely nominal or token extra solution components of the claims, and are nothing more than an attempt to generally link the system or method to a particular technological environment, and do not practically integrate the abstract idea into a complete system or method. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered separately and in combination do not add significantly more to the exception. The additional limitations only calculate or transmit data and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.05.
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of receiving data related to a target and location of a lead and stimulation criterion, identifying a value of a cost parameter that meet the stimulation criterion, and providing/transmitting the value of the cost parameter to a user or another system, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. processor, control unit, computer readable medium, etc.) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. In addition, the use of the lead and control unit are merely nominal or token extra solution components of the claims, and are nothing more than an attempt to generally link the system or method to a particular technological environment, and do not practically integrate the abstract idea into a complete system or method. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claim 13 having a control unit, lead, and processor, and corresponding method claim 1 not containing any physical element) is a system having a processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claims do not impose any limits on how the target and location of the lead, and stimulation criterion information are received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. In addition, the use of the lead and control unit are merely nominal or token extra solution components of the claims, and are nothing more than an attempt to generally link the system or method to a particular technological environment, and do not practically integrate the abstract idea into a complete system or method. The claim also does not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The control unit and processor are recited so generically (no details whatsoever are provided other than that they are a lead, control unit, and processor) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. In addition, the use of the lead and control unit are merely nominal or token extra solution components of the claims, and are nothing more than an attempt to generally link the system or method to a particular technological environment, and do not practically integrate the abstract idea into a complete system or method. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the processor and control unit. No element has been set forth to sense the lead target and location data, or stimulation criterion, and the only additional element is the lead, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/output of a cost value. In addition, the use of the lead and control unit are merely nominal or token extra solution components of the claims, and are nothing more than an attempt to generally link the system or method to a particular technological environment, and do not practically integrate the abstract idea into a complete system or method. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of receiving data related to a target and location of a lead and stimulation criterion, identifying a value of a cost parameter that meet the stimulation criterion, and providing/transmitting the value of the cost parameter to a user or another system, etc.), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, lines 5-8 are vague as it is unclear what limitations are being positively recited/claimed as part of the method/steps and what limitations are not being positively recited as steps of the method. The claim positively recites a step of identifying “values” of a cost parameter, however, it is unclear if the claim is also setting forth positive steps of how the cost parameter is calculated/determined. The claim uses a “wherein” clause that states that the cost parameter is “a ratio of cost of stimulation…target” but never actually sets forth a method step in active voice to “calculating a ratio of a cost…” and therefore it is unclear if determining the ratio is being positively recited as a step. It is also unclear if any value of a cost found in the prior art will meet the claim limitations, or if the prior art and claims actually need a step to “calculating a ratio of a cost…target”. As the claim does not use active voice in regards to calculating a ratio, any value of a cost parameter in the prior art will meet the relative and arbitrary value of a cost parameter in the claims. As set forth in the disclosure, the cost value is just a representation of stimulation fields/parameters for programming into the stimulation system, and therefore the cost value can be anything from a number, letter, or the actual stimulation values themselves to represent the stimulation fields/parameters that equate to the cost parameters. In addition, these “values” are relative and undefined.
Claims 5, 13, 14 and 17-18 use similar language and therefore are vague as explained above.
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, 4-9, 13-14, 16-18, and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Xiao et al (2017/0100601). Xiao discloses the claimed invention as follows:
--a lead with electrodes (e.g. figures 2 and 3, elements 102 and 104, etc.),
--a control unit for generating electrical stimulation for the lead (e.g. figure 6B, stimulation engine and/or processor, etc.)
--a processor (e.g. figures 5 and 6A, programmer, elements 604, 606, 608, 610, parts of a processor set forth in para. 31, etc.) that perform the following actions/method steps of:
--receiving a target location (e.g. brain tissue, the target of stimulation, para. 35, etc.)
--receiving a lead location (e.g. CT scan with lead, lead geometry in brain, paras. 12, 37, etc.).
--receiving stimulation criteria (e.g. max curve, representing a fixed amount of current, paras. 29, 52; maximum stimulation to the target region while minimizing side effect regions, paras. 53, 28; most overlap of stimulation of the target tissue, para. 9; etc.)
--identifying a “value” of a cost parameter that meet the stimulation criterion (i.e. where the value is a number, letter, or representation of when the cost parameter meets the stimulation criteria; Note the claim does not state the cost parameter is calculated and therefore the prior art only needs to meet the intended use of meeting a relative/arbitrary “value” of a cost. Xiao meets this intended use recitation of the value of a cost as follows: e.g. stimulation settings that are as closes a possible to achieving the value of the max curve, found in the abstract; stimulation settings that maximally stimulate a region while minimally stimulating side effect regions, para. 53; sum having coefficients, para. 53; paras. 53-54, etc.).
--providing the value(s) to a user or the stimulation system to assist in programming (e.g. figure 4, element 414; figure 5; paras. 29, 56, etc.) and for claims 8-9, 16 and 20, programming the device for stimulating the patient.
For claim 4, the user can select which cost value to use (e.g. para. 56, etc.). For claims 5, 14, and 18, note that the claims are not calculating the cost parameter, and therefore the prior art only has to be capable of meeting the functional/intended use recitation or meeting an arbitrary/undefined/relative “value”, which as described above, Xiao does. For claim 6, Xiao minimizes side effect regions (e.g. para. 53, etc.) and therefore receives them. For claim 7, Xiao discloses a plurality of stimulation volumes and fields are used to meet the stimulation of the target tissue and they can be pulled from a database (e.g. paras. 9, 11, etc.; where the actual stimulation parameters/fields/volumes are considered the “value”). For claim 17, the limitation of a computer readable medium, Xiao discloses the use of a processor, software, and/or memory to carry out the method (e.g. paras. 31, 33, 67-68, etc.).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao in view of Schouenborg et al (2018/0369589). Xiao discloses the claimed invention and applying the stimulation to meet the stimulation parameters, but does not disclose iteratively applying the stimulation to find the best stimulation, as disclosed in claims 10 and 11, of obtaining responses about the stimulation, altering the stimulation parameter and applying a second stimulation to get a response and querying whether the response meets a goal of one or more desired benefits without generating a side effect above a threshold. When the query result is negative, again repeating the altering, stimulating, and responses to see if the response meets a target of desired benefits without generating a side effect above a threshold. Schouenborg discloses continually applying stimulation, getting responses, altering the parameter, again applying stimulation (e.g. para. 11, claims 1-2, etc.) and querying for negative side effects looking for stimulation above a negative side effect threshold (e.g. paras. 39, 26, 186, 192,etc.) so that the most effective stimulation can be found that does not produce negative side effects. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Xiao, with obtaining responses about the stimulation, altering the stimulation parameter and applying a second stimulation to get a response and querying whether the response meets a goal of one or more desired benefits without generating a side effect above a threshold, and when the query result is negative, again repeating the altering, stimulating, and responses to see if the response meets a target of desired benefits without generating a side effect above a threshold, as taught by Schouenborg, since it would provide the predictable results of finding the most effective stimulation that does not produce negative side effects.
Allowable Subject Matter
Claims 2-3, 12, 15, and 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/ Primary Examiner, Art Unit 3792 1/24/26