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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IT102018000002962, filed on 02/22/2018.
Information Disclosure Statement
The information disclosure statement(s) filed 09/09/2024 has/have been considered by the Examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites, “Disclosed herein are…”, which is considered implied phraseology and should be avoided. The abstract further includes labeled parenthesis (i.e. apparatus (10)) which should be removed. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 37 and 40-42 objected to because of the following informalities:
Claims 37 and 40-42 contain labeled parenthesis (i.e. feedback capacitors (C5, C6) in claim 37) which should be removed. Appropriate correction is required.
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 26-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 24-42 recite a method for treating a neurological disorder, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
A method for treating a neurological disorder, the method comprising: receiving a neural activity signal from at least one implantable recording electrode implanted in the brain of a subject; amplifying and pre-filtering the neural activity signal by using a first stage comprising a fully-differential switched capacitor circuit configured for discrete-time signal processing, to generate an amplified, pre-filtered neural activity signal; and filtering the amplified, pre-filtered neural activity signal by cutting off frequencies above a predefined frequency band using a second stage comprising a fully-differential switched capacitor circuit configured for discrete-time signal processing, to generate a filtered neural activity signal; generating a command signal based on the filtered neural activity signal; and transmitting the command signal to a pulse generator operatively connected to at least one implantable stimulating electrode, wherein the command signal changes one or more parameters of electrical stimulation generated by the pulse generator and delivered by the at least one implantable stimulating electrode to stimulate a target brain region, thereby treating the neurological disorder.
Independent claim 1 is directed to abstract ideas, specifically to MENTAL PROCESSES, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a person could mentally receive a neural activity signal by looking at data and memorizing/processing the signal. A person could then mentally filter the neural signal by observing the neural signal and mentally extracting desired parts of the signal. A person could mentally transmit information or commands by pen and paper. A person could also change electrical stimulation parameters by mentally identifying or determining the appropriate stimulation parameters.
Dependent claims 27-42 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Specifically, dependent claims 27-42 only further define the abstract ideas (mental processes), and do not amount to significantly more than the abstract idea itself. Accordingly, the dependent claims are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 26-42 do not disclose using the result of the mental process steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, radiation therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process steps as stated above. The step of “transmitting the command signal to a pulse generator” can also be an additional element interpreted as a form of data transmission as an insignificant extra-solution activity by simply supplying a signal to a pulse generator without transforming the data transmission to result in delivery of stimulation to a patient to treat a particular condition, therefore the step of data transmission in the claims can be done without practical application to treat a particular condition. There is no specific treatment delivered to treat a particular condition that is specified in the claims, but is only directed to a form of simple data transmission (i.e. transmitting control signals). Accordingly, claims 26-42 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 26-42 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the computer elements (i.e. capacitors, filters, etc.), electrodes and pulse generators, but these elements have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes). By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis and data transfer). Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Accordingly, dependent claims 27-42 do not further recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited additional elements is/are recognized as generic computers (or computer components), and because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry.
As shown in the reference as taught by Bracke (US 20160143591 A1) which teaches a neurostimulation device (paragraph 0030 – “A medical device, such as an implantable medical device (IMD), may be configured to determine the resistance of tissue such as, e.g., human tissue. By determining the resistance of tissue, the IMD or a clinician can determine therapy parameters (e.g., amplitude) of electrical neurostimulation (e.g., voltage or current) outputted by the IMD to provide proper neurostimulation therapy”), and further teaches components including capacitor (paragraph 0033-0034), electrodes (figure 1, electrodes 24, 26; paragraph 0045) and pulse generator (paragraph 0045).
Additionally, Molnar (US 20120053659 A1) teaches a neurostimulation system (abstract – “A physiological signal of a patient is sensed with sense electrodes symmetrically arranged relative to a stimulation electrode. In some examples, a member includes a plurality of relatively small electrodes that are configured to function as both sense and stimulation electrodes. One or more of the electrodes may be selected as stimulation electrodes and two or more different electrodes of the member may be selected as sense electrodes that are symmetrically arranged relative to the one or more selected stimulation electrodes”), comprising processor for neural signal processing (paragraph 0092 – “In some examples, sensing module 46 or processor 40 may filter the signal from the sense electrodes in order to remove undesirable artifacts from the signal…”), and further includes electrodes (paragraph 0031) and pulse generator (paragraph 0033).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 26-42 are not patent eligible under 35 USC § 101.
Allowable Subject Matter
Claims 26-42 are allowed over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art searched found nothing to anticipate and/or render obvious to claim 26 in its entirety, including at least to the method for treating a neurological disorder comprising: receiving a neural activity signal from at least one implantable recording electrode implanted in the brain of a subject; amplifying and pre-filtering the neural activity signal by using a first stage comprising a fully-differential switched capacitor circuit configured for discrete-time signal processing, to generate an amplified, pre-filtered neural activity signal; and filtering the amplified, pre-filtered neural activity signal by cutting off frequencies above a predefined frequency band using a second stage comprising a fully-differential switched capacitor circuit configured for discrete-time signal processing, to generate a filtered neural activity signal; generating a command signal based on the filtered neural activity signal; and transmitting the command signal to a pulse generator operatively connected to at least one implantable stimulating electrode, wherein the command signal changes one or more parameters of electrical stimulation generated by the pulse generator and delivered by the at least one implantable stimulating electrode to stimulate a target brain region, thereby treating the neurological disorder, as claimed in claim 26. Dependent claims 27-42 are further allowed over the prior art for the same reasons.
Prior art searched includes Kurtz (US 20050228306 A1) which teaches a system for receiving neural signals (paragraph 0023) and filtering neural signals (paragraph 0027), but not explicitly state steps including amplifying and pre-filtering the neural activity signal by using a first stage comprising a fully-differential switched capacitor circuit configured for discrete-time signal processing and filtering the amplified, pre-filtered neural activity signal by cutting off frequencies above a predefined frequency band using a second stage comprising a fully-differential switched capacitor circuit configured for discrete-time signal processing, among the other claim limitations of claim 26.
Similarly, prior art searched also includes Cao (US 20200406041 A1) which teaches evoked response detection including a pre-filter/amplifier circuit (paragraph 0064), but similarly does not teach the limitations of claim 26 as stated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796