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 .
Status of Claims
Claims 1-15 and 33-37 are currently pending and under consideration.
In the pursuit of compact prosecution, a call was made to the patent practitioner of record, Kenichi Hartman, registration number 68,766, on June 11, 2026 to propose an examiner’s amendment to the application. However, this non-final office action is being sent out at the request of the Applicant, who respectfully denied the proposal for an examiner’s amendment on June 17, 2026.
Claim Objections
Claims 7 and 11 objected to because of the following informalities: C1(F2) and C2(F2) in claim 7 and Pmax(Pj) and Pmin(Pj) in claim 11 are not clear within the claim language. It is unclear whether these indicate, for example, C1 as a function of (F2) or C1 multiplied by (F2). It is described in the specification that, for example, C1 is a function of (F2). It is recommended that the applicant makes this clear in the claimed language to reflect the details of the specification. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a stimulation module configured to…”, “an acquisition module configured to…”, and “a processing module configured to…” in claim 1, lines 7, 10 and 12, respectively.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Paragraphs [0059 - 0062], [0063], and [0066] of the specification provide corresponding structure for the stimulation module, acquisition module, and processing module that includes a pulse generator, a waveform generator, acquisition electrodes, and a wireless transmission interface.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arlotti et. al (US 20180280699 A1, published 10/04/2018, hereinafter known as Arlotti).
Regarding claim 1, Arlotti discloses a device for adaptive treatment of neurological diseases comprising (“an apparatus for treating neurological disorders” [0016])
an implantable electrode configured to sense neural activity signals and apply electrical stimulation signals, and (“at least one electrode implantable in the brain of a patient” [0017])
a processing and stimulation unit connected to the implantable electrode (“processing and stimulation device connected to the at least one electrode” [0018]), wherein the processing and stimulation unit at least comprises:
a stimulation module configured to generate a stimulation signal to be carried at the implantable electrode, the stimulation signal being characterized by at least one stimulation parameter (“stimulation module adapted to generate a stimulation signal to be sent to the at least one electrode, the stimulation signal being characterized by a plurality of parameters” [0019]);
an acquisition module configured to record neural activity signal records of neural activity signals sensed by the implantable electrode (“acquisition module of a signal characteristic of cerebral activity coming from the brain of the patient, adapted to determine its power in at least one frequency band” [0020]); and
a processing module configured to process the neural activity signal records recorded by the acquisition module (“processing means for transforming the acquired signal characteristic of cerebral activity in the frequency domain” [0041]) based on a first control logic (“at least one control module of at least one parameter” [0021]) and to tune the at least one stimulation parameter (A) based on at least one neural activity signal record processed according to the first control logic (“adjusting at least one parameter of the stimulation signal as a function of the power of the acquired signal characteristic of cerebral activity based on a transfer function having a saturating trend… a control signal for a stimulation module is generated that sets the stimulation parameters” [0029] & [0062]), the first control logic being a function depending on at least one signal feature (Fi) of the neural activity signal records (“control module of at least one parameter of the stimulation signal as a function of the power of the acquired signal characteristic of cerebral activity” [0021]), being based on at least one control parameter (“based on a transfer function having a saturating trend, wherein the transfer function is such as to set said at least one parameter” [0021]) (Cj) and being made of a plurality of different function pieces (“transfer function having a saturating trend as a function of a plurality of power ranges is a piecewise function” [0035]), wherein each function piece of the plurality of different function pieces is related to a respective range of the at least one signal feature (“transfer function having a saturating trend is implemented as a piecewise function based on ranges of values of the input power” [0082]) (Fi), wherein the processing module is configured to process the neural activity signal records recorded by the acquisition module based on a second control logic (“processing means for transforming the acquired signal characteristic of cerebral activity in the frequency domain…at least one control module of at least one parameter” [0021] & [0041]) and to tune the at least one control parameter (Cj) of the first control logic based on at least one neural activity signal record processed according to the second control logic (“adjusting at least one parameter of the stimulation signal as a function of the power of the acquired signal characteristic of cerebral activity based on a transfer function having a saturating trend… a control signal for a stimulation module is generated that sets the stimulation parameters” [0029] & [0062]).
Regarding claim 37, Arlotti discloses a method for controlling a device for adaptive treatment of neurological diseases (“method for treating neurological disorders” [0014]) comprising the steps of:
- based on a first control logic (“at least one control module of at least one parameter” [0021]), processing neural activity signal records recorded by an acquisition module of the device for adaptive treatment of neurological diseases (“processing means for transforming the acquired signal characteristic of cerebral activity in the frequency domain” [0041]), wherein the first control logic is a function depending on at least one signal feature (“control module of at least one parameter of the stimulation signal as a function of the power of the acquired signal characteristic of cerebral activity” [0021]) (Fi) of the neural activity signal records, is based on at least one control parameter (Cj) and is made of a plurality of different function pieces (“transfer function having a saturating trend is implemented as a piecewise function based on ranges of values of the input power” [0082]), wherein each function piece of the plurality of different function pieces is related to a respective range of the at least one signal feature (Fi), (“transfer function having a saturating trend as a function of a plurality of power ranges is a piecewise function” [0035]);
- tuning at least one stimulation parameter (A) of a stimulation signal based on at least one neural activity signal record processed according to the first control logic (“adjusting at least one parameter of the stimulation signal as a function of the power of the acquired signal characteristic of cerebral activity based on a transfer function having a saturating trend… a control signal for a stimulation module is generated that sets the stimulation parameters” [0029] & [0062]);
- based on a second control logic, processing neural activity signal records recorded by the acquisition module (“processing means for transforming the acquired signal characteristic of cerebral activity in the frequency domain…at least one control module of at least one parameter” [0021] & [0041]), and
- tuning the at least one control parameter (Cj) of the first control logic based on at least one neural activity signal record processed according to the second control logic (“adjusting at least one parameter of the stimulation signal as a function of the power of the acquired signal characteristic of cerebral activity based on a transfer function having a saturating trend… a control signal for a stimulation module is generated that sets the stimulation parameters” [0029] & [0062]).
Allowable Subject Matter
Claims 2-15 and 33-36 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 1-15 and 33-37, the claimed subject matter contains the inventive concept of treating neurological diseases using a device that comprises a stimulation module, an acquisition module, and a processing module that records and processes neural activity signals based on a first and second control logic and a first and second timeseries.
Following a prior art search, the patent application most similar to the claimed subject matter includes the aforementioned prior art of Arlotti, US 20180280699 A1.
With respect to the prior art, Arlotti teaches the basic structure of the neurological disease treatment device including the stimulation, acquisition, and processing modules as mentioned in independent claims 1 and 37.
However, the prior art fails to teach the limitations of dependent claims 2-15 and 33-36. Among these limitations are the first and second timeseries of collected neural activity, the second control logic being a Bollinger bands calculator, unsupervised learning model, or time-based fuzzy controller, the piecewise functions of the first control logic, the upper and lower limits of the first control logic, the stimulation parameter windows of the processing and stimulation unit.
Within the prior art, there are references made to, time dynamics, merely for collecting data and not processing the data, a control logic, though it is not a Bollinger bands calculator, unsupervised learning model, or time-based fuzzy controller, and a piecewise function with minimum and maximum limit values, used for a transfer function and not a control logic. Therefore, the prior art does not teach the inventive concept and limitations as claimed in claims 2-15 and 33-36.
Conclusion
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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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