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 .
Election/Restrictions
Claims 4-6, 18, and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/11/26.
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 1-3, 7-12 and 28-34 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, the next to last line, “the responses evoked…” lacks antecedent basis. The claim has only set forth there are responses, but have not set forth there are “evoked” responses. In the next to last line “by at least one monopolar…” is vague as this term is also used in line 2. If they are the same element then “by the at least one…” should be used.
In claim 28, line 2, “to obtain one or more focused responses” , line 4, “a plurality of focused stimulation measurements”, and line 5, “a plurality of focused responses” are vague as claim 25 uses similar terms and it is unclear if they are the same element or not. If they are the same element then “the” should be used. If they are different elements, then a modifier such as “additional” should be used.
Similarly, in claims 29 and 30, “by monopolar stimulation”, “at least one monopolar stimulation measurement”, “by focused” are vague.
In claim 30, line 8, “the monopolar stimulation at least one…” seems to be misworded.
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 1-3, 7-16, 20-22, 25-26, and 28-34 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 measuring monopolar and focus stimulations and determining operational parameters from the measurements. This judicial exception is not integrated into a practical application because the combination of additional elements (e.g. processor and maybe a sensor; or non-transitory computer readable medium) fails to integrate the judicial exception into a practical application. The generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. In addition, if it is considered that the method has sensors for sensing the monopolar and focus stimulations, the sensors are insignificant extra solution activity and it is merely a nominal or token extra solution component of the claims, is nothing more than an attempt to generally link the method to a particular structure, and/or is meant to just gather data for the abstract idea/mental concept. 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 store, retrieve, and/or process 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 measuring monopolar and focus stimulations and determining operational parameters from the measurements, 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. process and maybe sensors, non-transitory 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. In addition, if it is considered that the method has sensors for sensing the monopolar and focus stimulations, the sensors are insignificant extra solution activity and it is merely a nominal or token extra solution component of the claims, is nothing more than an attempt to generally link the method to a particular structure, and/or is meant to just gather data for the abstract idea/mental concept. 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 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 25 have a non-transitory computer readable medium, and corresponding method claims 1 and 13) is a system having a memory for 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 monopolar and focused measurements/information is 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. 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.
Note that it is unclear if the method claims require any physical element, or require a sensor to take the measurements, or if the measurements are just data transmitted or observed. While claim 25 requires a computer readable storage medium, the measurements appear to be just data.
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 memory and executing processor are recited so generically (no details whatsoever are provided other than that they are a memory 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. 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 the memory. No element has been set forth to sense the monopolar and focused signals, and the only additional element is the memory, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/a determination of operation parameters. The memory limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim. In addition, if it is considered that the method has sensors for sensing the monopolar and focus stimulations, the sensors are insignificant extra solution activity and it is merely a nominal or token extra solution component of the claims, is nothing more than an attempt to generally link the method to a particular structure, and/or is meant to just gather data for the abstract idea/mental concept. 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 measuring monopolar and focus stimulations and determining operational parameters from the measurements, 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 § 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 1-3, 7-8, 10-16, 20-21, 25-26, 28-29, and 31-34 are rejected under 35 U.S.C. 102a1 as being anticipated by McLaughlin et al (2016/0228704). MacLaughlin discloses the claimed limitations as follows:
-performing monopolar stimulation measurements (e.g. figures 6, 10; paras. 12, 34, etc.)
-performing multiple focused stimulation measurements of the same type as the monopolar measurement (e.g. figures 6, 10; paras. 12, 34, 29, EFI or evoked measurements, paras. 12, 29-30, 42, etc.)
-determining one or more operation parameters based on the responses/evoked by the monopolar and focused stimulation measurements (e.g. M level, which channels or stimulation to use (e.g. paras. 12-13, 42, etc.)
Similarly, independent claims 13 and 25 are met by the above limitations of MacLaughlin where he uses a computer readable medium with instructions (e.g. para. 59, etc.)
For claims: 2, 16, and 26, performing objective measurements (e.g. EFI or evoked, paras. 12, 29-30, 42, 46, etc.); 3, performing ECAP measurements (e.g. para. 42, etc.); 7, 15, and 28, performing measurements with different degrees of focusing (e.g. para. 34, etc.); 8, estimating differences between the monopolar and focused measurements and setting parameters based on the differences (e.g. paras. 45-48, etc.); 10, 20, and 31, setting a degree of focusing (e.g. paras. 12, 13, 45, 47-51, 57, etc.); 11 and 33, setting a set of stimulation channels (e.g. paras. 23, 13, 47-51, etc.); 12 and 34, setting current steering parameters (e.g. paras. 12-13, 45, 47-51, 57, etc.); 21 and 29, setting parameters based on one or more differences in benefits (e.g. paras. 12, 13, 45, 57, etc.); and 32, during only certain sound environments (e.g. during normal operation, paras. 12, 53, etc.).
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 7/31/26
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