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 .
Response to Arguments
The drawing objections have been withdrawn in light of the amendments received on 2/18/2026. The 35 USC § 112 rejections of claims 1, 6 and 8 are also withdrawn in light of the amendments received on 2/18/2026.
Regarding claims 12-13, applicant's arguments filed 2/18/2026 have been fully considered but they are not persuasive. On page 8 of applicant’s response applicant argues that claims 12-13 have been amended and the rejection has been withdrawn. However, the claims are continue to recite a model, a machine learning model, a deep learning model, a neural network or an artificial intelligence model. These rejections are not withdrawn and are restated in this Final Office Action. There is no model including a machine learning model, a deep learning model, a neural network or an artificial intelligence model, is disclosed.
Applicant’s arguments with respect to claims 1-6 and 8-10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 12 recites: “further comprising inputting a first signal indicative of the neural activity into a model configured to determine that a parameter of the first signal satisfies a condition, wherein the model is one of a machine learning model, a deep learning model, a neural network, or an artificial intelligence model.”
Claim 13 recites: “further comprising inputting a signal indicative of the neural activity into a model configured to determine stimulation command based upon a detected condition, wherein the model is one of a machine learning algorithm, deep learning, a neural network, or an artificial intelligence model.”
The claim language found in claims 12-13 is considered to encompass computer-implemented functional limitations. In order to comply with the enablement requirement the specification must teach those skilled in the art now to make and use the full scope of the claimed intention without undue experimentation. Below is the Wands factor analysis
Breadth
The breadth of the claim language is expansive. Any and all machine learning algorithms, deep learning, neural networks and/or artificial intelligence is claimed.
Nature of the invention
The nature of the invention is complex.
State of the prior art
The state of the prior art is developing.
Level of skill of one or ordinary skill in the art
The level of skill of one or ordinary skill in the art is high.
Level of predictability in the art
The level of predictability is low.
Amount of direction provided by the inventors and Existence of working examples
With respect to the claim language in question there is little to no direction provided by the inventors and there are no working examples.
In this case there is no disclosure of an algorithm or any other steps and/or procedures which would indicate how the applicants intend to implement the machine learning algorithms, deep learning, neural networks and/or artificial intelligence, there is only a statement that these are contemplated. Therefore there is a failure of any specific teaching as to how the computer function is to be carried out which results in undue experimentation.
Claims 1 and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, lines 12-13 recite “wherein, the neural activity comprises an individual neuron activity at the target tissue site.” Under broadest reasonable interpretation, this includes recording from a single neuron (“an individual neuron activity”), this concept of recording from a single neuron is considered to be new matter. The specification provides not disclosure as to how applicant intends to record from a single neuron and not a group of neurons which produce a compound action potential, which is a summation of single neuron action potentials. For the sake of expedited prosecution it will be assumed that this is a compound action potential.
Claim 12 recites: “further comprising inputting a first signal indicative of the neural activity into a model configured to determine that a parameter of the first signal satisfies a condition, wherein the model is one of a machine learning model, a deep learning model, a neural network, or an artificial intelligence model.”
Claim 13 recites: “further comprising inputting a signal indicative of the neural activity into a model configured to determine stimulation command based upon a detected condition, wherein the model is one of a machine learning algorithm, deep learning, a neural network, or an artificial intelligence model.”
In order to satisfy written description the specification must describe the claimed intention, in this case the machine learning algorithm, deep learning, a neural network, or artificial intelligence, in sufficient detail so that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. In this case software must be written, there must be some disclosure as to how applicant intends to implement and construct the machine learning algorithm, deep learning, a neural network, or artificial intelligence. In this case the inventors have failed to provide any program or algorithm and therefore more than routing experimentation is necessary to develop the machine learning algorithm, deep learning, a neural network, or artificial intelligence.
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 1-7, 9-13 and 21 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.
Claim 1, lines 10-11 recite “sending, via the first electrode, a stimulating signal to the target tissue site; and simultaneously recording, via the second electrode, neural activity at the target”. The definition of the word “simultaneously” is in a simultaneous manner : at the same time : concurrently i. This language is indefinite in that based on physiology, if the stimulation electrode is spaced apart from the sensing electrode (as is in applicants figures 1A-C it is impossible to record in a simultaneous manner in that it will take time, on the order of milliseconds, for the action potential to travel from the stimulated tissue to the sensing electrodes. The use of the word simultaneously is therefore indefinite. For the purposes of examination it will be assumed that an action potential (ECAP) is recorded based on tissue stimulated at a stimulating electrode and received as soon as it passes the recording electrode.
Regarding claim 9: the claim recites “wherein the set of leads comprises a wireless transmitter or transceiver”. The amended specification, paragraph 0085, states that the wireless communication is within the device. It is unclear how the lead could have the wireless transmitter or transceiver. For the purpose of expedited prosecution it will be assumed that the wireless transceiver/transmitter is not within the lead but is within the device connected to the leads.
Regarding claim 10: the claim recites “further comprising receiving the recorded neural activity from a wireless transmitter coupled to the set of leads.” It is unclear where the recorded neural activity is received. It is assumed this is received at an external device.
The remainder of the claims not specifically addressed are also rejected in that they depend from previously rejected claims.
Claim Rejections - 35 USC § 102
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 1-2, 4-7, 11 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Troosters et al. US 2010/0222844.
Regarding claim 1: Troosters discloses a method of treating a condition (paragraph 0084 “the treatment of: Parkinson's disease, dyskinesia, essential tremor, epilepsy, pain, obsessive compulsive disorder (OCT), dystonia, torticollis, hemiparesis, speech impairment, cluster headaches, orthostatic hypotension, hypertension, Tourette’s syndrome, persistent vegetative state, and depression”) comprising;
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implanting a lead (figure 6) at a target tissue site (“neural tissue”, abstract; “cranial and peripheral nerves”, paragraph 0001), the lead includes a plurality of electrodes 32a-32d and 33a-33e (figure 6), the electrodes in figure 6 are spaced apart along a length of the lead, the electrodes comprising:
a first electrode having a first surface area 32a-32d (figure 6);
a second electrode 33a-33e (figure 6) which has a second smaller surface area and
stimulating using a stimulation signal, via the first electrode, the target tissue (figure 5, paragraph 0074); and
recording, via the second electrode, neural activity (APW, figure 5) at the target tissue site, wherein the neural activity comprises an individual neuron activity at the target tissue site (paragraphs 0013, 0036, 0067, 0069, 0087).
Troosters further discloses that, depending on the disease state, electrodes can be implanted bilaterally. This would include two leads implanted on opposing sides of the brain (paragraph 0085).
Regarding claim 2: Troosters discloses transmitting the recorded neural activity to an external device (paragraph 0038).
Regarding claim 4: Troosters discloses that the target tissue includes brain tissue (paragraph 0078).
Regarding claim 5: Troosters discloses determining a parameter of the neural activity, wherein the parameter comprises (paragraphs 0069, 0087).
Regarding claim 6: Troosters discloses a single lead (figure 6, paragraph 0079).
Regarding claim 7: Troosters discloses implanting leads bilaterally (paragraph 0085) these leads are deep brain stimulation leads (Troosters electrodes are considered leads), it is inherent that the leads are implanted at a depth.
Regarding claim 11: Troosters discloses a deep brain stimulating electrode implanted which would inherently require tissue resection (paragraphs 0055, 0078-0079).
Regarding claim 21: Troosters discloses recording action potentials (abstract “one or more action potentials”) which are well known in the art and include a summation of neural signals.
Claim Rejections - 35 USC § 103
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Troosters et al. US 2010/0222844 in view of Parker et al. US 2014/0236257.
Regarding claim 3: Troosters discloses the claimed invention however Troosters does not disclose continuous recording over minutes, hours, days, weeks or months. Parker however teaches of a method and apparatus for neural stimulation (abstract and title). Parker further teaches that the neural response measurements are used “substantially continuously” to adjust the system in real time (paragraph 0154), this is a feedback mechanism which uses the ECAP (“measured evoked response) as feedback. Parker further discloses that the trial stimulation can last for days setting up the feedback system (paragraph 0160). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Troosters to include continuous recording of ECAP signals over days or chronically, as taught by Parker, in order to utilized the ECAP as feedback for stimulation.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Troosters et al. US 2010/0222844 in view of Flaherty et al. US 2005/0283203.
Regarding claims 9-10: Troosters discloses the claimed invention including the use of wireless technology (paragraphs 0038 and 0072). However, Troosters does not disclose a wireless transmitter for transmitting data. Flaherty however teaches of module 70 (figure 5) of a neural access device 10 (figure 5) which includes a wireless transceiver and/or transmitter to communicate to and from an external device (paragraph 0085). Flaherty further teaches that detected signals are transmitted to a device for diagnostic purposes (paragraph 0031). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Troosters to include a wireless transmitter/transceiver to transit data, as taught by Flaherty, in order to exchange information (Flaherty, paragraph 0031).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Troosters et al. US 2010/0222844 in view of Botros et al. US 8,965,520.
Regarding claims 12-13: Troosters discloses the claimed invention however Troosters does not disclose inputting a signal indicative of neural activity into a machine learning model and determining a stimulation command based on the machine learning model. Botros however teaches of an automatic determination of a threshold of an evoked neural response using a machine learning model (“machine-learned expert system” title and abstract). Botros further teaches that the system is configured to determine if the measured NRT signal contains a neural response based on extracted features (column 4, lines 65-67). In this design incrementally increasing stimulation is applied to the neural tissue and NRT measurements are recorded the signal is then applied to a machine learning system to predict if a neural response is within the NRT (column 5, lines 50-62). If a neural response has not been evoked the system increases the stimulation level (column 6, lines 4-7). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Troosters to include applying a signal to a machine learning model to determine of the action potential is present and then use the determination to set stimulation amplitude, as taught by Botros, in order to set a stimulation threshold for finer stimulation resolution (column 6, lines 9-10 Botros).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i SIMULTANEOUSLY Definition & Meaning - Merriam-Webster: https://www.merriam-webster.com/dictionary/simultaneuosly