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 . 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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/27/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 04/27/2026 (“Amendment”). Claims 1-10 and 12-21 are currently under consideration. The Office acknowledges the amendments to claims 1 and 8.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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: “drug delivery device” in claim 1.
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 (e.g. for “drug delivery device,” drug delivery pump 142 as described in ¶ 0079 of the specification as filed).
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 § 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 1-10 and 12-21 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.
Regarding claim 1, there is no support for the distal end of the drainage catheter comprising the at least one electrode. ¶ 0058 of the specification as filed mentions that the electrodes are “in proximity to” the distal end, which is not the same as the distal end.
Claims 2-10 and 12-21 are rejected because they depend on rejected claims.
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.
Claims 1-10 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2010/0280335 (“Carlson”) in view of US Patent Application Publication 2010/0168532 (“Waziri”), US Patent Application Publication 2019/0082990 (“Poltorak”), and US Patent Application Publication 2019/0246989 (“Genov”).
Regarding claim 1, Carlson teaches [a] method comprising: … receiving electroencephalogram (EEG) data (¶ 0078) from the least one electrode placed in the brain of the subject (Fig. 1, electrodes 24 and 26), wherein at least a portion of [a] … catheter is placed in a cerebrospinal fluid (CSF)-containing space of the brain (Fig. 1, at least a portion being located in the hollow spaces, and delivering therapeutic agents to the brain as described in ¶ 0100); determining a current brain state of the global brain state or predicting a future brain state of the global brain state of the subject based on the EEG data using [an AI model] (¶ 0078); controlling a drug delivery device to administer treatment to the subject based on the determined current brain state or the predicted future brain state of the subject, wherein administering treatment comprises infusing a drug … to the CSF-containing space of the brain (Carlson: ¶¶s 0100, 0194-0196, e.g. delivering a therapeutic agent); … .
Carlson does not appear to explicitly teach placing a drainage catheter in a brain of a subject, wherein a distal end of the drainage catheter comprises at least one electrode placed in the brain of the subject and configured to record electrical activity indicative of a global brain state rather than a local region of the brain (although the leads/electrodes of Carlson do record activity indicative of global brain state – see e.g. ¶ 0078, describing the sum of electrical potential differences across brain tissue, as distinct from an LFP or action potentials). Carlson does not appear to explicitly teach infusing a drug through the drainage catheter.
Waziri teaches using an external ventricular drainage catheter together with implanted electrodes (¶¶s 0010, 0048, 0088, 0099, etc., for measuring brain activity, including activity from white matter (see ¶ 0017 of Applicant’s specification as filed)) in the context of managing elevated intracranial pressure and monitoring seizures and changes in brain function (¶¶s 0003, 0004, etc. – also see Fig. 1, drainage hole region 15 and electrode region 6 at the distal end of the catheter). The catheter can be used for intracranial delivery of therapeutic compounds (¶¶s 0073, 0078, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the catheter of Waziri in Carlson (or at least to implement the drainage portions therein), for the purpose of additionally managing intracranial pressure in an easy to use and consistent manner, based on comprehensive sensing (Waziri: ¶¶s 0003, 0004, 0010, etc.). It would have been obvious to use the catheter to infuse a drug for the purpose of administering treatment as already contemplated (Carlson: ¶¶s 0194-0196; Waziri: ¶¶s 0073, 0078, etc.).
Carlson-Waziri does not appear to explicitly teach determining or predicting a brain state using a deep neural network (DNN) (although it does contemplate the use of artificial neural networks in ¶¶s 0004, 0047, etc.).
Poltorak teaches using a deep neural network as an optimized statistical classifier (¶ 0590).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a DNN like the one of Poltorak in the combination as the simple substitution of one known AI model (the neural network or SVM of Carlson) for another (the deep neural network of Poltorak) with predictable results (determining the patient state, which is a classification – Carlson: ¶ 0078; Poltorak: ¶ 0590).
Carlson-Waziri-Poltorak does not appear to explicitly teach refining the DNN based on additional EEG data that is collected after the administered treatment.
Genov teaches using unsupervised (unlabeled) learning to perform classification, and then refining the learning with supervised (labeled) learning (¶¶s 0045, 0078, etc., refining a model, including incrementally).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use unsupervised learning in the combination for the purpose of being able to distinguish normal neural activity from segments of clinical interest easily and automatically, without user input (Genov: ¶ 0045), and then to use supervised learning to improve or further detail the classification (e.g. by labeling irregular recording periods observed over time), preparing the classifier for closed-loop applications (Genov: ¶ 0045).
Regarding claim 2, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches wherein the determined current brain state or the predicted future brain state is associated with a disease of the brain of the subject (Carlson: ¶ 0085, seizure, movement disorder, etc.).
Regarding claim 3, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches wherein the catheter comprises an external ventricular drainage catheter or a ventriculoperitoneal shunt (Waziri: ¶¶s 0003, 0004, etc. – also see Fig. 1, drainage hole region 15 and electrode region 6 at the distal end of the catheter).
Regarding claim 4, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches wherein the catheter comprises a therapeutic agent delivery catheter (Carlson: ¶ 0100).
Regarding claim 5, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches wherein the at least one electrode is placed in white matter of the brain (Carlson: Fig. 1, as shown - also see ¶ 0068, etc., describing deep brain stimulation).
Regarding claim 6, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches wherein determining the current brain state or predicting the future brain state comprising determining a current brain state associated with a disease of the brain or predicting a future brain state associated with a disease of the brain by identifying electrical signal biomarkers associated with the disease of the brain (Carlson: ¶¶s 0085, 0047).
Regarding claim 7, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches wherein determining the current brain state or predicting the future brain state comprises determining a current psychiatric brain state or predicting a future psychiatric brain state (Carlson: ¶ 0058, mood state or psychiatric disorder).
Regarding claims 8-10 and 12, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches comprising administering treatment to the subject in response to the current brain state or the predicted future brain state in the brain state data (Carlson: ¶¶s 0194, 0195), wherein treatment is administered before onset of a predicted future brain state of the subject (Carlson: ¶ 0194, alert that a seizure is about to occur), wherein administering treatment comprises providing an alert to the subject, a healthcare provider, or a caretaker (Carlson: ¶ 0194, as above), wherein the treatment comprises a treatment for one or more of the following: epilepsy, bipolar disorder, depressive disorder spectrum, anxiety disorder spectrum including post-traumatic stress disorder (PTSD), cognitive disorder spectrum, memory disorder spectrum, processing speed disorder spectrum subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, extradural hemorrhage, obstructive hydrocephalus, nervous system cancer (including secondary malignant neoplasm of the brain, spinal cord, or other parts of the nervous system; malignant neoplasm of the cerebellum nos; malignant lymphoma of an unspecified site, extranodal site, or solid organ site), cerebral artery occlusion, unspecified cerebral infarction, closed fracture of the base of the skull (associated with one or more of subarachnoid hemorrhage, subdural hemorrhage, extradural hemorrhage, and loss of consciousness), infection and inflammatory reaction (due to nervous system device, implant or graft), mechanical complication of a nervous system device, implant or graft, traumatic brain injury, congenital hydrocephalus, and aneurysms (Carlson: ¶¶s 0058 (depression), 0065 (seizure), 0100).
Regarding claim 13, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches wherein determining the current brain state or the predicted future brain state comprises receiving EEG data from two or more electrodes (Carlson: Fig. 1, electrodes 24 and 26 - also see Fig. 5 and related description).
Regarding claims 14 and 15, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches receiving other data than the EEG data and wherein the other data is used in determining the current brain state or predicting the future brain state (Carlson: ¶¶s 0090, 0112), wherein the other data comprises one or more of the following types of data corresponding to the subject: activity, motion, heart rate, visual stimuli, audio or video recordings, and skin conductance (Carlson: ¶ 0090).
Regarding claim 16, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches receiving labeling data to label a brain state relative to the EEG data and training the DNN based on the labeling data and the EEG data (Carlson: ¶¶s 0152 and 0153, the seizure being detected by the EEG data of Fig. 5 - also note that Fig. 5 shows a supervised learning technique, which uses labeled data (Carlson: ¶¶s 0169-0171, etc.); Poltorak: ¶ 0590, labeled training data).
Regarding claims 17-20, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov further teaches training the DNN based on unlabeled EEG data, training the DNN using unsupervised or semi-supervised feature learning to identify electrical biomarkers associated with brain states from the EEG data, and training the DNN using different data to refine the DNN after unsupervised or semi-supervised feature learning to train the DNN, wherein training the DNN using different data to refine the DNN comprises using supervised feature learning using labeled data to refine the DNN (Genov teaches using unsupervised (unlabeled) learning to perform classification, and then refining the learning with supervised (labeled) learning (¶ 0045). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use unsupervised learning in the combination for the purpose of being able to distinguish normal neural activity from segments of clinical interest easily and automatically, without user input (Genov: ¶ 0045), and then to use supervised learning to improve or further detail the classification, preparing the classifier for closed-loop applications (Genov: ¶ 0045)).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson-Waziri-Poltorak-Genov in view of US Patent Application Publication 2021/0327029 (“Chen”).
Regarding claim 21, Carlson-Waziri-Poltorak-Genov teaches all the features with respect to claim 1, as outlined above. Carlson-Waziri-Poltorak-Genov does not appear to explicitly teach wherein the DNN comprises a contrastive learning model.
Chen teaches using a contrastive learning model (¶¶s 0096 and 0100) in a DNN model (¶¶s 0087 and 0093).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a contrastive learning model in the DNN model of the combination, as in Chen, to improve processing (Chen: Fig. 1, performing on par with or better than a strong supervised baseline as described in ¶ 0031 – also see ¶ 0033) without requiring specialized architecture or a memory bank (Chen: Abstract, ¶ 0027).
Response to Arguments
Applicant’s arguments filed 04/27/2026 have been fully considered.
The amendments and arguments with respect to the rejections under 35 USC 103 are not persuasive. Carlson itself does not preclude recording electrical activity indicative of a global brain state. There is nothing suggesting that its sensors only record e.g. from gray matter, or even that gray matter does not include activity indicative of “global” brain state. ¶ 0078 of Carlson describes detecting potential differences across brain tissue, EEG, etc., as distinct from an LFP or action potentials. Further, Waziri explicitly describes sensing from white matter, which Applicant acknowledges is indicative of global brain state (¶ 0017 of the specification as filed).
All claims remain rejected in light of the prior art.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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