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 .
Remarks
In response to communications sent November 27, 2025, claim(s) 1, 3, 5, 9-11, 19, 24, 27, 33-38, 40, 41, 47, 48, 51, 53, and 55-57 is/are pending in this application; of these claim(s) 1 is/are in independent form. Claim(s) 2, 4, 6-8, 12-18, 20-23, 25, 26, 28-32, 39, 42-46, 49, 50, 52, 54, 58, and 59 is/are cancelled.
Information Disclosure Statement
The Information Disclosure Statement(s) is/are acknowledged and the references contained therein have been considered by the Examiner. This includes the Information Disclosure Statements(s) filed on: November 27, 2025
Response to Arguments
Applicant's arguments filed November 27, 2025 have been fully considered but they are not persuasive. Regarding the non-statutory double-patenting rejections:
The intended use in the preamble is not a step in the body of the claim. Hence differences between the reference claims and the instant claims that are merely in the preamble have little patentable weight.
Applicant argues that Slepian (US 20180292888 A1) does not teach administering a non-digital therapeutic. The Examiner respectfully disagrees. Administering a therapeutic is taught in Paragraphs [0026], [0096], [0097], [0117], and [0118]. Therefore, each of the non-statutory double patenting rejections are not withdrawn.
Applicant's arguments filed November 27, 2025 have been fully considered but they are not persuasive. Regarding the rejection under 35 U.S.C. § 112(a), Applicant argues that deleting the element of Creutzfeldt-Jakob disease from claim 34 overcomes the rejection for claims 1, 3, 5, 9-11, 19, 24, 27, 33, 35-38, 40, 41, 47, 48, 51, 53, and 55-57. The Examiner respectfully disagrees. The scope of the independent claim includes the element of “neuro-degenerative disease.” According to Applicant’s Specification at para [00035] and [00111], the element of “neuro-degenerative disease” encompasses Creutzfeldt-Jakob disease, even though it is not expressly enumerated in the independent claim. Hence, the dependent claims include this element, with the exception of claim 34, which includes a closed-ended set of neuro-degenerative diseases that do not include Creutzfeldt-Jakob disease. Therefore, the rejection of claims 1, 3, 5, 9-11, 19, 24, 27, 33, 35-38, 40, 41, 47, 48, 51, 53, and 55-57 is not withdrawn.
Applicant's arguments filed November 27, 2025 have been fully considered but they are not persuasive. Regarding the rejection under 35 U.S.C. § 112(a), Applicant argues that the rejection of claim 34 under 35 U.S.C. § 112(a) should be withdrawn because various conditions are listed for which the neuro-connectivity discoveries predict success in multiple conditions. However, Applicant’s Remarks, filed November 27, 2025, on page 10 line 23 to page 11 line 13 admits that one of ordinary skill in the art would not connect improvements to immune function and increases to neuro-connectivity. Therefore the rejection of claim 34 is not withdrawn.
Applicant's arguments filed November 27, 2025 have been fully considered but they are not persuasive. Regarding 35 U.S.C. § 101, Applicant argues that the unexpected results amounts to an inventive concept. The Examiner respectfully disagrees because unexpected abstract results from abstract ideas are still abstract ideas and a judicial exception. Note that novelty and obviousness are a different inquiry from evaluation of judicial exceptions. Applicant argues that the claimed invention is not a high level of generality due to tangible results and unexpected results. However, in the rejection, it is the step of administration that is at a high level of generality, which differs from the Vanda, which involved a particular treatment. Furthermore, the overall level of generality of the claims as a whole is not the basis of the rejection, because a specific and particular judicial exception, in the absence of an inventive concept or integration, is still a judicial exception. Last, the tangibility of an single element is not a standalone test for eligibility of the claim as a whole.
Applicant's arguments filed November 27, 2025 have been fully considered but they are not persuasive. Regarding 35 U.S.C. § 102: applicant amended the claim so that the sensory inhibition, sensory substitution, and sensory integration are narrow elements requiring a conjunction. However, the claim recites the set of various types of digital interventions using the alternative. Hence, only one of the digital interventions needs to be mapped. The four alternatives are “sensory inhibition,” “sensory substitution,” “sensory integration,” and “a combination thereof.” The elements are in the alternative because of the use of the word “or” as a disjunction. This is the case even though each individual type of digital intervention is limited to a conjunction.
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, 3, 5, 9-11, 19, 24, 27, 33-38, 40, 41, 47, 48, 51, 53, and 55-57 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a maze-based digital therapeutic for the conditions illustrated in the data-driven figures, does not reasonably provide enablement for treating, preventing, or alleviating Creutzfeldt-Jakob disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Creutzfeldt-Jakob disease is a prion disease with no known cure, and the Specification does not present evidence of the successful treatment, prevention, or alleviation of the illness using any model system. It appears that treatment, prevention, or alleviation of this condition, at the very least, is prophetic. Because the condition of Creutzfeldt-Jakob disease is incurable, undue experimentation would be needed for one of ordinary skill in the art to be able to practice the invention.
Regarding claim 34, Applicant’s Remarks, filed November 27, 2025, on page 10 line 23 to page 11 line 13 admits that one of ordinary skill in the art would not connect improvements to immune function and increases to neuro-connectivity. Therefore, the teachings in the specification regarding neuro-connectivity have a relation to neurological conditions resulting from immune impairment that is merely a prophetic relation.
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, 5, 9-11, 19, 24, 27, 33-38, 40, 41, 47, 48, 51, 53, and 55-57 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “at least one sensory modality input”, and the claim also recites “consisting of visual, auditory, and tactile” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input”, and the claim also recites “consists of: visual to auditory and/or tactile; auditory to visual and/or tactile; and tactile to visual and/or auditory” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “at least two sensory modalities inputs”, and the claim also recites “at least two sensory modalities consist of: visual, auditory, and tactile” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 3, 5, 9-11, 19, 24, 27, 33-38, 40, 41, 47, 48, 51, 53, and 55-57 are rejected because they depend from claim 1.
For the purpose of compact prosecution, the Examiner assumes that the narrower interpretations were intended.
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.
The claims are directed to a process, which is a statutory class. However:
Claims 1, 3, 5, 9-11, 19, 24, 27, 33-38, 40, 41, 47, 48, 51, 53, and 55-57 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a method of organizing human activity without significantly more. The claim(s) recite(s) psychological intervention, which is a “method of managing personal behavior” noted in MPEP § 2106.04(a)(2)(C). For example, MPEP instructs that judicial exceptions include “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)”. This judicial exception is not integrated into a practical application because the additional elements amount to applying the psychological intervention with the aid of a general purpose computer by “applying it” on the computer. The Vanda conditions for integration into a practical application do not apply, because the treatments proposed are not specific treatments, instead recited at a high level of generality. See Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because mere instructions to apply a judicial exception on a general purpose computer are not significantly more based on legal precedent (MPEP § 2106.05(f)).
Regarding the dependent claims, many of the claims limit only the method of organizing human activities (claims 2, 3, 9 10, 11, 13, 15, 17, 24, and 27); are the mere use of a general purpose computer (claim 4, 19, and 27). Claim 5 uses insignificant pre-solution activity according to precedent as mere data gathering (MPEP § 2106.05(g)). Claims 27 and 57 also recite a mental process to adjust the method of organizing human behavior, but combining judicial exceptions amounts to judicial exception. In claims 33-41, 47, 48, 51, 53, and 55, Applicant limits the judicial exception to treatments of conditions, but the treatments and conditions are recited at a high level of generality as large sets of many possible treatments for large sets of many possible conditions. Hence the requirement for integration into a practical application are not met due to the high level of generality.
1. A method of increasing neuro-connectivity in an individual affected by a neuro-degenerative disease or a neurological disorder or a psychological disorder (a treatment of a disease recited at a high level of generality, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)), said method comprising:
providing a personal electronic device (general purpose computer) to receive data related to the individual and the neuro-degenerative diseases or the neurological disorder or the psychological disorder (insignificant pre-solution activity necessary to carry-out the abstract idea);
implementing the digital therapy intervention plan (this is a method of organizing human activities) for the individual carried out at least partially on the personal electronic device (general purpose computer);
wherein the digital therapy intervention plan comprises at least one digital intervention configured for the interaction of the individual, the at least one digital intervention comprising: sensory inhibition, sensory substitution, sensory integration, or a combination thereof, wherein the digital therapy intervention plan further comprises modifying at least one sensory modality input on the personal electronic device during implementation of the digital therapy intervention plan, presenting it to the individual and monitoring the responses of the individual (the Examiner interprets this as a psychological intervention, as in claim 3, which is a “method of managing personal behavior” noted in MPEP § 2106.04(a)(2)(C); since it is a digital intervention it is applied on a general purpose computer);
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input consists of: visual , auditory, and tactile (methods organizing human activity by managing personal behavior);
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input, wherein the sensory substitution consists of:
visual to auditory and/or tactile (the broadest reasonable interpretation of “and/or” is “or”; methods organizing human activity by managing personal behavior);
auditory to visual and/or tactile (the broadest reasonable interpretation of “and/or” is “or”; methods organizing human activity by managing personal behavior); and
tactile to visual and/or auditory (the broadest reasonable interpretation of “and/or” is “or”; methods organizing human activity by managing personal behavior);
and wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities consist of: visual, auditory, and tactile (methods organizing human activity by managing personal behavior); and
administering medicinal agent before, during, after, or a combination thereof, said at least one digital intervention (this element is not a specific treatment or prophylactic because it is recited at a high level of generality); and
adapting the digital therapy intervention plan based on the responses of the individual (readjustments of judicial exceptions is post-solution activity according to Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) and 437 U.S. at 590; 198 USPQ at 197; Id.; see MPEP § 2106.05(g) “Insignificant Extra-Solution Activity” which recites to Parker v. Flook as “holding that step of adjusting an alarm limit variable to a figure computed according to a mathematical formula was "post-solution activity"; the same claims were noted as well-understood, routine, and conventional as “recomputing or readjusting alarm limit values”.)
3. The method of claim 1 wherein said digital intervention comprises: at least one psychological intervention, at least one cognitive intervention (this is a method of managing personal behavior), at least one physical intervention, or a combination thereof.
5. The method of claim 1 further comprising the personal electronic device being configured to onboard data for said individual wherein said data is selected from personal, demographic, medical, biomarker information, medicinal agent intake and dosage regimen, geographic, environmental, lifestyle, health and wellbeing, biometric, behavioral, digital intervention related data, goal setting, medical considerations, preferences, availability, time constraints, scheduling, individual’s strengths and weaknesses, cultural considerations, communication channel preference, feedback from said individual, feedback from healthcare provider, or a combination thereof (transferring data is insignificant pre-solution activity as mere data gathering according to MPEP § 2106.05(g)); for use in personalization of the digital therapy intervention plan (mental process).
9. The method of claim 3 wherein said at least one psychological intervention is selected from: guided imagery, psychoeducation, psychotherapy (this is a method of organizing human activity, and it is recited in the alternative), cognitive behavioral therapy, stress and anxiety management training, mindfulness-based interventions, body scanning training, sleep hygiene, fatigue training, acceptance and commitment therapy (ACT), dialectical behavior therapy (DBT), psychodynamic therapy, solution-focused brief therapy (SFBT), narrative therapy, pain therapy, addiction therapy, gestalt therapy, behavioral activation therapy, telepsychiatry and teletherapy or a combination thereof (these elements are recited in the alternative).
10. The method of claim 3 wherein said at least one cognitive intervention is selected from: navigation in a maze (this element, recited in the alternative, is similar to the case cited in MPEP for organizing human activity by managing personal behavior: “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)”), spatial navigation, magic-7 training, memory enhancement techniques, attention training, problem-solving, sonification exercise, data visualization, geometric puzzles, shape and pattern matching, visual perception tasks, spatial reasoning games, face detection training, drawing game, focus training, reading training, or any combination thereof (these elements are recited in the alternative).
11. The method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy, swallow therapy, breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof (these are methods of organizing human activity by managing personal behavior).
19. The method of claim 1 wherein the interaction is selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof ; and wherein the adapting is executed in response to the interaction (insignificant extra-solution activity as mere data gathering as per MPEP § 2106.05(g)).
24. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game (a method organizing human activity as a game played according to rules), instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof (these elements are recited in the alternative).
27. The method of claim 5 further comprising an adaptation plan, during the course of said digital therapy intervention plan, comprising:
receiving said data (insignificant extra-solution activity as per MPEP § 2106.05(g));
receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention (methods of organizing human behavior), said at least one physical intervention (claimed in the alternative), or a combination thereof;; and
generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data (a mental process to update a method of organizing human behavior).
33. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neuro-degenerative disease (a treatment of a disease recited at a high level of generality, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
34. The method of claim 33 wherein said neuro-degenerative disease is selected from: Alzheimer's disease, Parkinson's disease, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), frontotemporal dementia, chronic traumatic encephalopathy (CTE), Lewy body dementia (LBD), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), Huntington's disease, and Wilson's disease (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
35. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neurologic disorder (although this is a treatment, it is recited at a high level of generality and the condition it is treated is recited at a high level of generality, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
36. The method of claim 35 wherein said neurologic disorder is selected from: Mild cognitive impairment (MCI), sleep disorders, migraine and headache disorders, neuropathies, epilepsy, traumatic brain injury, spinal cord injury, and cerebrovascular diseases (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
37. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a psychological disorder (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
38. The method of claim 37 wherein said psychological disorder is selected from: depression, anxiety, bipolar disorder, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), attention-deficit/hyperactivity disorder (ADHD), eating disorders, substance use disorder, sleep disorders, autism spectrum disorder (ASD), personality disorders, schizophrenia, and dissociative disorders (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
39. The method of claim 1 wherein said non-digital medical intervention is selected from: medicinal agent, medical procedures, physiotherapy, psychotherapy, psychiatry, rehabilitation, lifestyle interventions, nutritional supplement, mineral supplement, and physical exercise (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
40. The method of claim 1 wherein said medicinal agent is selected from: dopaminergic agent, anti-amyloid beta antibody, opioids, immune checkpoint inhibitors, NMDA receptor antagonist, triptans, acetylcholinesterase inhibitor, neuro-steroids, anti-inflammatory agents, neuroprotective agents, mitochondrial support agents, metabolic therapy, hormone therapy, Tau-targeted therapy, beta-secretase inhibitors, gamma-secretase modulators, psychedelic drug, or a combination thereof (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
41. The method of claim 40 wherein said dopaminergic agent is selected from: dopamine precursor, dopamine agonist, monoamine oxidase inhibitors (MAOIs), or a combination thereof (the treatment recite is specific, but the condition being treated is recited at a high level of generality, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)) .
47. The method of claim 40 wherein said immune checkpoint inhibitors are selected from: PD-1 inhibitors, pembrolizumab, nivolumab, cemiplimab, PD-L1 inhibitors, avelumab, atezolizumab, durvalumab, CTLA-4 inhibitors, ipilimumab, tremelimumab, LAG-3 inhibitors, relatlimab, TIM-3 inhibitors, sabatolimab, TIGIT inhibitors, tiragolumab, domvanalimab, CD40 agonists, selicrelumab, OX40 agonists, utomilumab, GITR agonists, tiragolumab, IDO1 inhibitors, VISTA inhibitors, B7-H3 inhibitors, or a combination thereof (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
48. The method of claim 40 wherein said NMDA receptor antagonist is selected from: SAGE-718, memantine, dextromethorphan (DXM), phencyclidine (PCP), methoxetamine (MXE), and nitrous oxide (N2O), ketamine, or a combination thereof (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
51. The method of claim 40 wherein said anti-inflammatory agent is selected from: nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, biologic drugs, or a combination thereof (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
53. The method of claim 40 wherein said neuroprotective agent is selected from: allopregnanolone, dehydroepiandrosterone, pregnenolone, progesterone, androstenediol, estradiol, testosterone, ketamine, riluzole, antioxidants, vitamin e, vitamin c, alpha-lipoic acid, omega-3 fatty acids, coenzyme q10 (CoQ10), ginkgo biloba extract, melatonin, resveratrol, nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), glutathione, magnesium, l-carnitine, carnosine, n-acetylcysteine (NAC), curcumin, quercetin, green tea extract, bacopa monnieri, ginseng, huperzine A, or a combination thereof (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
55. The method of claim 39 wherein said medicinal agent is administered by: injection, orally, topically, inhalation, transdermal, intranasal, intravenous, intramuscular, subcutaneous, or a combination thereof (although this is a treatment of a disease, the scope of the disease is a set that collectively is a high level of generality and the treatment itself is not specific, unlike Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018)).
56. The method of claim 5 further configured such that said digital therapy intervention plan is configured to account for said individual’s medicinal intake, dosage regimen and non-digital medical intervention schedule, to achieve said increase in neuro-connectivity (mental process).
57. The method of claim 39 wherein said medicinal agent, said at least one digital intervention, or a combination therein, is administered together with a conditioning stimulus selected from: visual, auditory, tactile, or a combination thereof (method of organizing human activity similar to the case cited in MPEP for organizing human activity by managing personal behavior: “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)”).
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.
Claim(s) 1, 3, 5, 9-11, 19, 24, 27, 33-38, 40, 41, 47, 48, 51, 53, and 55-57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180292888 A1 (“Slepian”).
As to claim 1, Slepian teaches a method of increasing neuro-connectivity in an individual affected by a neuro-degenerative disease (Slepian Para [0023]: for the treatment of Anorexia, which the Examiner interprets to result in at least some starvation-induced neural degeneration) or a neurological disorder or a psychological disorder, (Slepian Para [0023]: associating and learning something new, which the Examiner interprets to involve at least one new neuron connection in an individual with Anorexia Nervosa), said method comprising:
providing a personal electronic device (Slepian Para [0075]: the digital intervention occurs using a portable computer) to receive data related to the individual and the neuro-degenerative diseases or the neurological disorder or the psychological disorder (Slepian Para [0023]: to receive data for the treatment of Anorexia, which the Examiner interprets to result in at least some starvation-induced neural degeneration) ;
implementing the digital therapy intervention plan for the individual carried out at least partially on the personal electronic device (Slepian Para [0039]: the virtual reality game is part of an overall treatment plan).;
wherein the digital therapy intervention plan comprises at least one digital intervention configured for the interaction of the individual (Slepian Para [0023]: a digital game to intervene for the condition of Anorexia Nervosa), the at least one digital intervention comprising: sensory inhibition (Slepian Para [0039]: a virtual reality environment, in which at least some environmental, e.g., visual, information from the actual environment is, by definition, reduced in order to present a virtual surrounding; Slepian Para [0049]: visual, auditory and/or multi-stimulatory experience becomes virtual; Para [0051] defines a multisensory therapy as including “tactile” multisensory therapy), sensory substitution (the sensory substitution does not need to be mapped, as long as sensory inhibition or sensory integration is mapped; nevertheless, see Slepian Para [0039]: a virtual reality environment, in which at least some tactile information is replaced with visual and/or audio information; see also Para [0023]: “to experience this [somaticized response] and may associate this with one or more of a positive sound, a pleasant vision, and a pleasurable smell, thereby substituting one type of somaticized response for an alternative sensory feeling”), sensory integration (the sensory integration does not need to be mapped, as long as sensory inhibition or sensory substitution is mapped; nevertheless, see Slepian Para [0024]: a combination of a visual headset and audio headphones facilitates the virtual reality game), or a combination thereof (the combination does not need to be mapped as long as at least one of the sensory inhibition, sensory substitution, or sensory integration is mapped), wherein the digital therapy intervention plan further comprises modifying at least one sensory modality input on the personal electronic device during implementation of the digital therapy intervention plan (Slepian Para [0024]: the virtual imager is dynamic and therefore has some visual modifications of the environment presented), presenting it to the individual (Slepian Para [0041]: utilizing biofeedback methodologies) and monitoring the responses of the individual (Slepian Para [0061]: monitoring sensors in order to prepare to use a machine learning algorithm to learn from the sensors to adjust the treatment model);
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input consists of: visual (Slepian Para [0039]: a virtual reality environment, in which at least some visual information from the actual environment is, by definition, reduced in order to present a virtual surrounding), auditory (Slepian Para [0049]: a virtual reality environment, in which at least some information from the actual environment is, by definition, reduced in order to present a virtual surrounding; specifically, auditory experience becomes virtual), and tactile (Slepian Para [0049]: a virtual reality environment, in which at least some information from the actual environment is, by definition, reduced in order to display a present surrounding; specifically, a multi-stimulatory experience becomes virtual; Para [0051] defines a multisensory therapy as including “tactile” multisensory therapy);
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input (the sensory substitution does not need to be mapped, as long as sensory inhibition or sensory integration is mapped; nevertheless, see Para [0023]: “to experience this [somaticized response] and may associate this with one or more of a positive sound, a pleasant vision, and a pleasurable smell, thereby substituting one type of somaticized response for an alternative sensory feeling”), wherein the sensory substitution consists of:
visual to auditory and/or tactile (the sensory substitution does not need to be mapped, as long as sensory inhibition or sensory integration is mapped; hence the limitation of the alternative to the alternative does not need to be mapped; nevertheless, see Para [0023]: “to experience this [somaticized response] and may associate this with one or more of a positive sound, a pleasant vision, and a pleasurable smell, thereby substituting one type of somaticized response for an alternative sensory feeling”);
auditory to visual and/or tactile (the sensory substitution does not need to be mapped, as long as sensory inhibition or sensory integration is mapped; hence the limitation of the alternative to the alternative does not need to be mapped; nevertheless, see Para [0023]: “to experience this [somaticized response] and may associate this with one or more of a positive sound, a pleasant vision, and a pleasurable smell, thereby substituting one type of somaticized response for an alternative sensory feeling”); and
tactile to visual and/or auditory (the sensory substitution does not need to be mapped, as long as sensory inhibition or sensory integration is mapped; hence the limitation of the alternative to the alternative does not need to be mapped; nevertheless, see Para [0023]: “to experience this [somaticized response] and may associate this with one or more of a positive sound, a pleasant vision, and a pleasurable smell, thereby substituting one type of somaticized response for an alternative sensory feeling”);
and wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities consist of: visual, auditory, and tactile (the sensory integration does not need to be mapped, as long as sensory inhibition or sensory substitution is mapped; nevertheless, see Slepian Para [0024]: a combination of a visual headset and audio headphones facilitates the virtual reality game); and
administering medicinal agent before (Slepian Para [0023]: prescribed therapy), during, after, or a combination thereof, said at least one digital intervention (Slepian Para [0023]: a digital game to improve adherence to the prescribed therapy; this can also involve the pill taught in Para [0054] as a medicinal agent); and
adapting the digital therapy intervention plan based on the responses of the individual (Slepian Para [0061]: using a machine learning algorithm to learn from therapy feedback and adjust the treatment model).
As to claim 3, Slepian teaches the method of claim 1 wherein said digital intervention comprises: at least one psychological intervention (Slepian Para [0023]: therapy), at least one cognitive intervention (Slepian Para [0023]: the digital game) at least one physical intervention (Slepian Para [0023]: prescribed therapy), or a combination thereof (Slepian Para [0023]: a combination of therapies and a digital game).
As to claim 5, Slepian teaches the method of claim 2 further comprising transferring data for said individual (Slepian Para [0040]: monitoring data from the anorexic individual) wherein said data is selected from: personal, demographic (these elements are recited in the alternative and do not all need to be mapped), medical (Slepian Para [0040]: weight information), biomarker information, medicinal agent intake and dosage regimen, geographic, environmental, lifestyle, health and wellbeing, biometric, behavioral, digital intervention related data, goal setting, medical considerations, health and wellbeing, preferences, availability, time constraints, scheduling, individual’s strengths and weaknesses, cultural considerations, communication channel preference, feedback from said individual, feedback from healthcare provider, or a combination thereof (these elements are recited in the alternative and do not all need to be mapped); and further comprising analyzing said data by means of machine learning (Slepian Para [0061]: a learning algorithm in a computer), artificial intelligence (AI), statistical modeling, or a combination thereof (these elements are recited in the alternative and do not all need to be mapped), to adapt said digital therapy intervention plan (Slepian Para [0061]: using a machine learning algorithm to learn from therapy feedback and adjust the treatment model).
As to claim 9, Slepian teaches the method of claim 3 wherein said at least one psychological intervention is selected from: guided imagery (these elements are recited in the alternative and do not all need to be mapped), psychoeducation (Slepian Para [0023]: educating an anorexic patient using a game setting), psychotherapy, cognitive behavioral therapy, stress and anxiety management training, mindfulness-based interventions, body scanning training, sleep hygiene, fatigue training, acceptance and commitment therapy (ACT), dialectical behavior therapy (DBT), psychodynamic therapy, solution-focused brief therapy (SFBT), narrative therapy, pain therapy, addiction therapy, gestalt therapy, behavioral activation therapy, telepsychiatry and teletherapy or a combination thereof (these elements are recited in the alternative and do not all need to be mapped).
As to claim 10, Slepian teaches the method of claim 3 wherein said at least one cognitive intervention is selected from: navigation in a maze (this element is recited in the alternative and does not need to be mapped), spatial navigation (Slepian Para [0021]: virtual environment immersion), magic-7 training, memory enhancement techniques, attention training, problem-solving, sonification exercise, data visualization, geometric puzzles, shape and pattern matching, visual perception tasks, spatial reasoning games, face detection training, drawing game, focus training, reading training, or any combination thereof (these elements are recited in the alternative and does not need to be mapped).
As to claim 11, Slepian teaches the method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy (these elements are recited in the alternative and does not need to be mapped), swallow therapy (Slepian Para [0023]: change in lifestyle for anorexia), breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof (these elements are recited in the alternative and does not need to be mapped).
As to claim 19, Slepian teaches the method of claim 1 wherein the interaction is selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction (these elements are recited in the alternative and therefore do not all need to be mapped), sensor-based interactions (Slepian Para [0027]: feedback sensors for interactions in the virtual reality environment), or a combination thereof (this element is recited in the alternative and does not need to be mapped); and wherein the adapting is executed in response to the interaction (Slepian Para [0061]: using a machine learning algorithm to learn from sensor feedback and adjust the treatment model).
As to claim 24, Slepian teaches the method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual (these elements are recited in the alternative and do not need to all be mapped), game (Slepian Para [0023]: a digital game), instructional prompts, question and answer survey with feedback (these elements are recited in the alternative and do not all need to be mapped), virtual reality (Slepian Para [0020]: virtual reality), augmented reality, or a combination thereof (these elements are recited in the alternative and do not all need to be mapped).
As to claim 27, Slepian teaches the method of claim 5 further comprising an adaptation plan, during the course of said digital therapy intervention plan, comprising:
receiving said data (Slepian Para [0061]: sensing patient conditions);
receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention, said at least one physical intervention, or a combination thereof (Slepian Para [0061]: receiving therapy feedback, which involves therapy and treatment described in the mapping of the independent claim);
analyzing said data and said updated data by means of machine learning, artificial intelligence (AI), or statistical modeling (Slepian Para [0061]: using a machine learning algorithm to learn from therapy feedback and adjust the treatment model); and
generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data (Slepian Para [0061]: adjusting the treatment model).
As to claim 33, Slepian teaches the method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neuro-degenerative disease (Slepian Para [0023]: for the treatment of Anorexia, which the Examiner interprets to result in at least some starvation-induced neural degeneration).
As to claim 34, Slepian teaches the method of claim 33 wherein said neuro-degenerative disease is selected from: Alzheimer's disease (Slepian Para [0056] and the following Table 1: the system can also be used of Alzheimer’s disease) , Parkinson's disease, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), frontotemporal dementia, chronic traumatic encephalopathy (CTE), Lewy body dementia (LBD), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), Huntington's disease, and Wilson's disease (these elements are recited in the alternative and do not all need to be mapped).
As to claim 35, Slepian teaches the method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neurologic disorder (Slepian Para [0023]: the Examiner interprets Anorexia Nervosa to be a neurological disorder in some cases).
As to claim 36, Slepian teaches the method of claim 35 wherein said neurologic disorder is selected from: Mild cognitive impairment (MCI), sleep disorders, migraine and headache disorders, neuropathies, epilepsy, traumatic brain injury, spinal cord injury (these elements are recited in the alternative and therefore don’t need to be mapped), and cerebrovascular diseases (Slepian Para [0056] and the following Table 1: the system can also be used of hypertension).
As to claim 37, Slepian teaches the method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a psychological disorder (Slepian Para [0023]: the Examiner interprets Anorexia Nervosa to be a psychological disorder in some cases).
As to claim 38, Slepian teaches the method of claim 37 wherein said psychological disorder is selected from: depression, anxiety, bipolar disorder, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), attention-deficit/hyperactivity disorder (ADHD) (these elements are recited in the alternative and do not all need to be mapped), eating disorders (Slepian Para [0023]: the Examiner interprets Anorexia Nervosa to be an eating disorder), substance use disorder, sleep disorders, autism spectrum disorder (ASD), personality disorders, schizophrenia, and dissociative disorders (these elements are recited in the alternative and do not all need to be mapped).
As to claim 39, Slepian teaches the method of claim 1 wherein said non-digital medical intervention is selected from: medicinal agent, medical procedures, physiotherapy, psychotherapy, psychiatry (these elements are recited in the alternative and do not all need to be mapped), rehabilitation, lifestyle interventions (Slepian Para [0023]: the non-digital intervention would be therapy for anorexia, which generally includes lifestyle interventions), nutritional supplement, mineral supplement, and physical exercise (these elements are recited in the alternative and do not all need to be mapped).
As to claim 40, Slepian teaches the method of claim 39 wherein said medicinal agent is selected from: dopaminergic agent, anti-amyloid beta antibody, opioids, immune checkpoint inhibitors, NMDA receptor antagonist, triptans, acetylcholinesterase inhibitor, neuro-steroids, anti-inflammatory agents, neuroprotective agents, mitochondrial support agents, metabolic therapy, hormone therapy, Tau-targeted therapy, beta-secretase inhibitors, gamma-secretase modulators, psychedelic drug, or a combination thereof (Slepian Para [0052]: the same system can involve a medical agent such a metabolic treatments or hormonal treatments).
As to claim 41, Slepian teaches the method of claim 40 wherein said dopaminergic agent is selected from: dopamine precursor, dopamine agonist, monoamine oxidase inhibitors (MAOIs), or a combination thereof (this element further limits the element of a dopaminergic agent; however, the dopaminergic element is recited in the alternative and therefore does not need to be mapped, even though it has been more narrowly defined in claim 41).
As to claim 47, Slepian teaches the method of claim 40 wherein said immune checkpoint inhibitors are selected from: PD-1 inhibitors, pembrolizumab, nivolumab, cemiplimab, PD-L1 inhibitors, avelumab, atezolizumab, durvalumab, CTLA-4 inhibitors, ipilimumab, tremelimumab, LAG-3 inhibitors, relatlimab, TIM-3 inhibitors, sabatolimab, TIGIT inhibitors, tiragolumab, domvanalimab, CD40 agonists, selicrelumab, OX40 agonists, utomilumab, GITR agonists, tiragolumab, IDO1 inhibitors, VISTA inhibitors, B7-H3 inhibitors, or a combination thereof (this element further limits the element of an immune checkpoint inhibitor; however, the immune checkpoint inhibitor element is recited in the alternative and therefore does not need to be mapped).
As to claim 48, Slepian teaches the method of claim 40 wherein said NMDA receptor antagonist is selected from: SAGE-718, memantine, dextromethorphan (DXM), phencyclidine (PCP), methoxetamine (MXE), and nitrous oxide (N2O), ketamine, or a combination thereof (this element further limits the element of an NMDA receptor antagonist; however, the NMDA receptor antagonist element is recited in the alternative and therefore does not need to be mapped).
As to claim 51, Slepian teaches the method of claim 40 wherein said anti-inflammatory agent is selected from: nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, biologic drugs, or a combination thereof (this element further limits the element of an inflammatory agent; however, the inflammatory-agent element is recited in the alternative and therefore does not need to be mapped).
As to claim 53, Slepian teaches the method of claim 40 wherein said neuroprotective agent is selected from: allopregnanolone, dehydroepiandrosterone, pregnenolone, progesterone, androstenediol, estradiol, testosterone, ketamine, riluzole, antioxidants, vitamin e, vitamin c, alpha-lipoic acid, omega-3 fatty acids, coenzyme q10 (CoQ10), ginkgo biloba extract, melatonin, resveratrol, nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), glutathione, magnesium, l-carnitine, carnosine, n-acetylcysteine (NAC), curcumin, quercetin, green tea extract, bacopa monnieri, ginseng, huperzine A, or a combination thereof (this element further limits the element of a neuroprotective agent; however, the neuroprotective element is recited in the alternative and therefore does not need to be mapped).
As to claim 55, Slepian teaches the method of claim 39 wherein said medicinal agent is administered by: injection (this element is recited in the alternative and does not need to be mapped), orally (Slepian Para [0054]: oral ingestion of adjunctive pills), topically, inhalation, transdermal, intranasal, intravenous, intramuscular, subcutaneous, or a combination thereof (these elements are recited in the alternative and do not all need to be mapped).
As to claim 56, Slepian teaches the method of claim 5 further configured such that said digital therapy intervention plan is configured to account for said individual’s medicinal intake (Slepian Para [0052]: a medication compliance), dosage regimen and (Slepian Para [0052]: a medicine regiment) non-digital medical intervention schedule (Slepian Para [0052]: taking into account habitual compliance to a medication regimen), to achieve said increase in neuro-connectivity (Slepian Para [0052]: the system involves a medical agent along with the digital treatment).
As to claim 57, Slepian teaches the method of claim 39 wherein said medicinal agent, said at least one digital intervention, or a combination therein, is administered together with a conditioning stimulus selected from: visual, auditory, tactile, or a combination thereof (Slepian Para [0066]: “By creating this positive mental state within patient 108, the patient's brain generates neurotransmitter chemicals (e.g., a balance of dopamine and serotonin) that are very beneficial to the medical treatment.” The Examiner argues that this chemical response is the Pavlovian conditioning stimulus alluded to in Slepian Para [0004]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5, 9-11, 19, 24, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 9-11, 19, 24, and 27 of copending Application No. 18/645889 (reference application) in view of US 20180292888 A1 (“Slepian”). The claims are initially identical but for the additional element of a “non-digital intervention,” the amended elements, and a different use that is in the preamble instead of in the body of the claim. However, the additional elements are taught by the secondary reference, Slepian Para [0023], Para [0039], and Para [0075]. The claims of the reference application and Slepian are in the same field of digital therapeutics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the claims of the reference application to include the teachings of Slepian because a digital game for sensory substitution can intervene in the condition of Anorexia Nervosa (See Slepian Para [0023]).
This is a provisional nonstatutory double patenting rejection.
Instant Application 18/645,588
Reference Application 18/645889
1. A method of increasing neuro-connectivity in an individual affected by a neuro-degenerative disease or a neurological disorder or a psychological disorder, said method comprising:
providing a personal electronic device to receive data related to the individual and the neuro-degenerative diseases or the neurological disorder or the psychological disorder;
implementing the digital therapy intervention plan for the individual carried out at least partially on the personal electronic device;
wherein the digital therapy intervention plan comprises at least one digital intervention configured for the interaction of the individual, the at least one digital intervention comprising: sensory inhibition, sensory substitution, sensory integration, or a combination thereof, wherein the digital therapy intervention plan further comprises modifying at least one sensory modality input on the personal electronic device during implementation of the digital therapy intervention plan, presenting it to the individual and monitoring the responses of the individual;
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input consists of: visual , auditory, and tactile;
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input, wherein the sensory substitution consists of:
visual to auditory and/or tactile;
auditory to visual and/or tactile; and
tactile to visual and/or auditory;
and wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities are selected from: visual, auditory, and tactile; and
administering medicinal agent before, during, after, or a combination thereof, said at least one digital intervention; and
adapting the digital therapy intervention plan based on the responses of the individual.
1. A method of improving immune function in an individual affected by an immune-related disorder, said method comprising:
providing a personal electronic device to receive data related to the individual; generating a digital therapy intervention plan based on the data;
implementing the digital therapy intervention plan for the individual, carried out at least partially on the personal electronic device,
wherein the digital therapy intervention plan comprises at least one digital intervention, configured for the interaction of the individual, comprising: sensory inhibition, sensory substitution, sensory integration, or a combination thereof, wherein the digital therapy intervention plan further comprises modifying at least one sensory modality input on the personal electronic device during implementation of the digital therapy intervention plan, presenting it to the individual and monitoring the responses of the individual;
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input is selected from: visual, auditory, and tactile;
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input selected from:
visual to auditory and/or tactile; auditory to visual and/or tactile; and tactile to visual and/or auditory;
wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities inputs are selected from: visual, auditory, and tactile; and
administering at least one non-digital medical intervention before, during, after, or a combination thereof, said at least one digital intervention; and
adapting the digital therapy intervention plan based on the responses of the individual and the administering of at least one non-digital medical intervention.
3. The method of claim 1 wherein said digital intervention comprises: at least one psychological intervention, at least one cognitive intervention, at least one physical intervention, or a combination thereof.
3. The method of claim 1 wherein said digital intervention comprises: at least one psychological intervention, at least one cognitive intervention, at least one physical intervention, or a combination thereof.
5. The method of claim 1 further comprising the personal electronic device being configured to onboard data for said individual wherein said data is selected from: personal, demographic, medical, biomarker information, medicinal agent intake and dosage regimen, geographic, environmental, lifestyle, health and wellbeing, biometric, behavioral, digital intervention related data, goal setting, medical considerations, preferences, availability, time constraints, scheduling, individual’s strengths and weaknesses, cultural considerations, communication channel preference, feedback from said individual, feedback from healthcare provider, or a combination thereof; for use in personalization of the digital therapy intervention plan.
See claim 1 in view of Slepian. The claims of the reference application and Slepian are in the same field of digital therapeutics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the claims of the reference application to include the teachings of Slepian because a digital game can intervene in the condition of Anorexia Nervosa (See Slepian Para [0023]).
9. The method of claim 3 wherein said at least one psychological intervention is selected from: guided imagery, psychoeducation, psychotherapy, cognitive behavioral therapy, stress and anxiety management training, mindfulness-based interventions, body scanning training, sleep hygiene, fatigue training, acceptance and commitment therapy (ACT), dialectical behavior therapy (DBT), psychodynamic therapy, solution-focused brief therapy (SFBT), narrative therapy, pain therapy, addiction therapy, gestalt therapy, behavioral activation therapy, telepsychiatry and teletherapy or a combination thereof.
9. The method of claim 3 wherein said at least one psychological intervention is selected from: guided imagery, psychoeducation, psychotherapy, cognitive behavioral therapy, stress and anxiety management training, mindfulness-based interventions, body scanning training, sleep hygiene, fatigue training, acceptance and commitment therapy (ACT), dialectical behavior therapy (DBT), psychodynamic therapy, solution-focused brief therapy (SFBT), narrative therapy, pain therapy, addiction therapy, gestalt therapy, behavioral activation therapy, telepsychiatry and teletherapy or a combination thereof.
10. The method of claim 3 wherein said at least one cognitive intervention is selected from: navigation in a maze, spatial navigation, magic-7 training, memory enhancement techniques, attention training, problem-solving, sonification exercise, data visualization, geometric puzzles, shape and pattern matching, visual perception tasks, spatial reasoning games, face detection training, drawing game, focus training, reading training, or any combination thereof.
10. The method of claim 3 wherein said at least one cognitive intervention is selected from: navigation in a maze, spatial navigation, magic-7 training, memory enhancement techniques, attention training, problem-solving, sonification exercise, data visualization, geometric puzzles, shape and pattern matching, visual perception tasks, spatial reasoning games, face detection training, drawing game, focus training, reading training, or any combination thereof.
11. The method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy, swallow therapy, breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof.
11. The method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy, swallow therapy, breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof.
19. The method of claim 1 wherein the interaction is selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof ; and wherein the adapting is executed in response to the interaction.
19. The method of claim 4 wherein said interaction is selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof, and wherein the adapting is executed in response to the interaction..
24. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof.
24. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof.
27. The method of claim 5 further comprising an adaptation plan, during the course of said digital therapy intervention plan, comprising: receiving said data; receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention, said at least one physical intervention, or a combination thereof; and generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data.
27. The method of claim 1, wherein the adapting comprises: receiving said data; receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention, said at least one physical intervention, or a combination thereof, analyzing said data and said updated data by means of machine learning, artificial intelligence (AI), or statistical modeling; and generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data.
Claims 1, 3, 5, 9-11, 19, 24, 27, and 33-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 5, 9-11, 19, 24, 27, and 33-38 of copending Application No. 18/645524 in view of US 20180292888 A1 (“Slepian”). The claims are almost identical but for the additional element of a “medicinal agent”. However, this is additional element is taught by the secondary reference, Slepian Para [0023] combined with Para [0054]. The claims of the reference application and Slepian are in the same field of digital therapeutics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the claims of the reference application to include the teachings of Slepian because a digital game for sensory substitution can intervene in the condition of Anorexia Nervosa (See Slepian Para [0023]).
This is a provisional nonstatutory double patenting rejection.
Instant Application 18/645,588
Reference Application 18/645524
1. A method of increasing neuro-connectivity in an individual affected by a neuro-degenerative disease or a neurological disorder or a psychological disorder, said method comprising:
providing a personal electronic device to receive data related to the individual and the neuro-degenerative diseases or the neurological disorder or the psychological disorder;
implementing the digital therapy intervention plan for the individual carried out at least partially on the personal electronic device;
wherein the digital therapy intervention plan comprises at least one digital intervention configured for the interaction of the individual, the at least one digital intervention comprising: sensory inhibition, sensory substitution, sensory integration, or a combination thereof, wherein the digital therapy intervention plan further comprises modifying at least one sensory modality input on the personal electronic device during implementation of the digital therapy intervention plan, presenting it to the individual and monitoring the responses of the individual;
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input consists of: visual , auditory, and tactile;
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input, wherein the sensory substitution consists of:
visual to auditory and/or tactile;
auditory to visual and/or tactile; and
tactile to visual and/or auditory;
and wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities are selected from: visual, auditory, and tactile; and
administering medicinal agent before, during, after, or a combination thereof, said at least one digital intervention; and
adapting the digital therapy intervention plan based on the responses of the individual.
1. A method of increasing neuro-connectivity in an individual, said method comprising: the individual carrying out at least one digital intervention comprising: sensory inhibition,
sensory substitution, sensory integration, or a combination thereof.
The additional element is taught by Slepian Para [0023].
The claims of the reference application and Slepian are in the same field of digital therapeutics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the claims of the reference application to include the teachings of Slepian because a digital game can intervene in the condition of Anorexia Nervosa (See Slepian Para [0023]).
3. The method of claim 1 wherein said digital intervention comprises: at least one psychological intervention, at least one cognitive intervention, at least one physical intervention, or a combination thereof.
3 in view of Slepian. The method of claim 1 wherein said digital intervention comprises: at least one psychological intervention, at least one cognitive intervention, at least one physical intervention, or a combination thereof.
5. The method of claim 1 further comprising the personal electronic device being configured to onboard data for said individual wherein said data is selected from: personal, demographic, medical, biomarker information, medicinal agent intake and dosage regimen, geographic, environmental, lifestyle, health and wellbeing, biometric, behavioral, digital intervention related data, goal setting, medical considerations, preferences, availability, time constraints, scheduling, individual’s strengths and weaknesses, cultural considerations, communication channel preference, feedback from said individual, feedback from healthcare provider, or a combination thereof; for use in personalization of the digital therapy intervention plan.
5 in view of Slepian. The method of claim 2 further comprising transfer of data for said individual wherein said data is selected from: personal, demographic, medical, biomarker information, medicinal agent intake and dosage regimen, geographic, environmental, lifestyle, health and wellbeing, biometric, behavioral, digital intervention related data, goal setting, medical considerations, health and wellbeing, preferences, availability, time constraints, scheduling, individual's strengths and weaknesses, cultural considerations, communication channel preference, feedback from said individual, feedback from healthcare provider, or a combination thereof; and further comprising analyzing said data by means of machine learning, artificial intelligence (AI), statistical modeling, or a combination thereof, to adapt said digital therapy intervention plan and further comprising analyzing said data by means of machine learning, artificial intelligence (AI), statistical modeling, or a combination thereof, to adapt said digital therapy intervention plan.
9. The method of claim 3 wherein said at least one psychological intervention is selected from: guided imagery, psychoeducation, psychotherapy, cognitive behavioral therapy, stress and anxiety management training, mindfulness-based interventions, body scanning training, sleep hygiene, fatigue training, acceptance and commitment therapy (ACT), dialectical behavior therapy (DBT), psychodynamic therapy, solution-focused brief therapy (SFBT), narrative therapy, pain therapy, addiction therapy, gestalt therapy, behavioral activation therapy, telepsychiatry and teletherapy or a combination thereof.
9 in view of Slepian. The method of claim 3 wherein said at least one psychological intervention is selected from: guided imagery, psychoeducation, psychotherapy, cognitive behavioral therapy, stress and anxiety management training, mindfulness-based interventions, body scanning training, sleep hygiene, fatigue training, acceptance and commitment therapy (ACT), dialectical behavior therapy (DBT), psychodynamic therapy, solution-focused brief therapy (SFBT), narrative therapy, pain therapy, addiction therapy, gestalt therapy, behavioral activation therapy, telepsychiatry and teletherapy or a combination thereof.
10. The method of claim 3 wherein said at least one cognitive intervention is selected from: navigation in a maze, spatial navigation, magic-7 training, memory enhancement techniques, attention training, problem-solving, sonification exercise, data visualization, geometric puzzles, shape and pattern matching, visual perception tasks, spatial reasoning games, face detection training, drawing game, focus training, reading training, or any combination thereof.
10 in view of Slepian. The method of claim 3 wherein said at least one cognitive intervention is selected from: navigation in a maze, spatial navigation, magic-7 training, memory enhancement techniques, attention training, problem-solving, sonification exercise, data visualization, geometric puzzles, shape and pattern matching, visual perception tasks, spatial reasoning games, face detection training, drawing game, focus training, reading training, or any combination thereof.
11. The method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy, swallow therapy, breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof.
11 in view of Slepian. The method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy, swallow therapy, breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof.
19. The method of claim 1 wherein the interaction is selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof ; and wherein the adapting is executed in response to the interaction.
19 in view of Slepian. The method of claim 4 wherein said digital intervention comprises said individual interacting with said personal electronic device using any of the following means selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof.
24. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof.
24 in view of Slepian. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof.
27. The method of claim 5 further comprising an adaptation plan, during the course of said digital therapy intervention plan, comprising: receiving said data; receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention, said at least one physical intervention, or a combination thereof; and generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data.
27 in view of Slepian. The method of claim 5 further comprising an adaptation plan, during the course of said digital therapy intervention plan, comprising: receiving said data; receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention, said at least one physical intervention, or a combination thereof; analyzing said data and said updated data by means of machine learning, artificial intelligence (AI), or statistical modeling; and generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data.
33. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neuro-degenerative disease.
33 in view of Slepian. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neuro-degenerative disease.
34. The method of claim 33 wherein said neuro-degenerative disease is selected from: Alzheimer's disease, Parkinson's disease, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), frontotemporal dementia, chronic traumatic encephalopathy (CTE), Lewy body dementia (LBD), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), Huntington's disease, and Wilson's disease.
34 in view of Slepian. The method of claim 33 wherein said neuro-degenerative disease is selected from: Alzheimer's disease, Parkinson's disease, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), frontotemporal dementia, chronic traumatic encephalopathy (CTE), Lewy body dementia (LBD), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), Huntington's disease, Creutzfeldt-Jakob disease and Wilson's disease.
35. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neurologic disorder.
35 in view of Slepian. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neurologic disorder.
36. The method of claim 35 wherein said neurologic disorder is selected from: Mild cognitive impairment (MCI), sleep disorders, migraine and headache disorders, neuropathies, epilepsy, traumatic brain injury, spinal cord injury, and cerebrovascular diseases.
36 in view of Slepian. The method of claim 35 wherein said neurologic disorder is selected from: Mild cognitive impairment (MCI), sleep disorders, migraine and headache disorders, neuropathies, epilepsy, traumatic brain injury, spinal cord injury, and cerebrovascular diseases.
37. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a psychological disorder.
37 in view of Slepian. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a psychological disorder.
38. The method of claim 37 wherein said psychological disorder is selected from: depression, anxiety, bipolar disorder, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), attention-deficit/hyperactivity disorder (ADHD), eating disorders, substance use disorder, sleep disorders, autism spectrum disorder (ASD), personality disorders, schizophrenia, and dissociative disorders.
38 in view of Slepian. The method of claim 37 wherein said psychological disorder is selected from: depression, anxiety, bipolar disorder, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), attention-deficit/hyperactivity disorder (ADHD), eating disorders, substance use disorder, sleep disorders, autism spectrum disorder (ASD), personality disorders, schizophrenia, and dissociative disorders.
Claims 1, 5, 11, 19, 24, 27, and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 20, 23, and 31 of copending Application No. 18/645948 in view of US 20180292888 A1 (“Slepian”). The claims are almost identical but for the additional element of a “non-digital intervention” and because the preambles differ in the intended use of the invention without the use being recited as a step in the body of the claim. However, the is additional element of the “non-digital intervention” is taught by the secondary reference, Slepian Para [0023]. The claims of the reference application and Slepian are in the same field of digital therapeutics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the claims of the reference application to include the teachings of Slepian because a digital game for sensory substitution can intervene in the condition of Anorexia Nervosa (See Slepian Para [0023]).
This is a provisional nonstatutory double patenting rejection.
Instant Application 18/645,588
Reference Application 18/645948
1. A method of increasing neuro-connectivity in an individual affected by a neuro-degenerative disease or a neurological disorder or a psychological disorder, said method comprising:
providing a personal electronic device to receive data related to the individual and the neuro-degenerative diseases or the neurological disorder or the psychological disorder;
implementing the digital therapy intervention plan for the individual carried out at least partially on the personal electronic device;
wherein the digital therapy intervention plan comprises at least one digital intervention configured for the interaction of the individual, the at least one digital intervention comprising: sensory inhibition, sensory substitution, sensory integration, or a combination thereof, wherein the digital therapy intervention plan further comprises modifying at least one sensory modality input on the personal electronic device during implementation of the digital therapy intervention plan, presenting it to the individual and monitoring the responses of the individual;
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input consists of: visual , auditory, and tactile;
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input, wherein the sensory substitution consists of:
visual to auditory and/or tactile;
auditory to visual and/or tactile; and
tactile to visual and/or auditory;
and wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities are selected from: visual, auditory, and tactile; and
administering medicinal agent before, during, after, or a combination thereof, said at least one digital intervention; and
adapting the digital therapy intervention plan based on the responses of the individual.
1. A method of improving motor skills in an individual affected by a movement disorder, said method comprising:
providing a personal electronic device to receive data related to the individual and the movement disorder;
generating a digital therapy intervention plan based on the data;
implementing the digital therapy intervention plan for the individual, carried out at least partially on the personal electronic device, wherein the digital therapy intervention plan comprises at least one digital intervention configured for the interaction of the individual in a physical intervention based on: sensory inhibition, sensory substitution, sensory integration, or a combination thereof, wherein the at least one digital intervention is implemented by modifying at least one sensory modality input on the personal electronic device, presenting it to the individual and monitoring the response of the individual;
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input is selected from: visual, auditory, and tactile;
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input selected from: visual to auditory and/or tactile; auditory to visual and/or tactile; and tactile to visual and/or auditory;
wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities inputs are selected from: visual, auditory, and tactile; and adapting the digital therapy intervention plan based on the response of the individual.
5. The method of claim 1 further comprising the personal electronic device being configured to onboard data for said individual wherein said data is selected from: personal, demographic, medical, biomarker information, medicinal agent intake and dosage regimen, geographic, environmental, lifestyle, health and wellbeing, biometric, behavioral, digital intervention related data, goal setting, medical considerations, preferences, availability, time constraints, scheduling, individual’s strengths and weaknesses, cultural considerations, communication channel preference, feedback from said individual, feedback from healthcare provider, or a combination thereof; for use in personalization of the digital therapy intervention plan.
See claim 1.
11. The method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy, swallow therapy, breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof.
See claim 1.
19. The method of claim 1 wherein the interaction is selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof ; and wherein the adapting is executed in response to the interaction.
15 in view of Slepian. The method of claim 1 wherein said interaction is selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof, and wherein the adapting is executed in response to the interaction.
24. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof.
20 in view of Slepian. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof.
27. The method of claim 5 further comprising an adaptation plan, during the course of said digital therapy intervention plan, comprising: receiving said data; receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention, said at least one physical intervention, or a combination thereof; and generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data.
23 in view of Slepian. The method of claim 4 wherein the adapting further comprises generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data.
57. The method of claim 39 wherein said medicinal agent, said at least one digital intervention, or a combination therein, is administered together with a conditioning stimulus selected from: visual, auditory, tactile, or a combination thereof.
31 in view of Slepian. The method of claim 1 wherein said at least one digital intervention is administered together with a conditioning stimulus selected from: visual, auditory, tactile, or a combination thereof.
Claims 1, 3, 5, 9-11, 19, 24, 27, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5, 9-11, 19, 24, 27, and 37 of copending Application No. 18/645,843 in view of US 20180292888 A1 (“Slepian”). The claims are almost identical but for the additional element of a “non-digital intervention” and because the preambles differ in the intended use of the invention without the use being recited as a step in the body of the claim. However, the is additional element of the “non-digital intervention” is taught by the secondary reference, Slepian Para [0023]. The claims of the reference application and Slepian are in the same field of digital therapeutics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the claims of the reference application to include the teachings of Slepian because a digital game for sensory substitution can intervene in the condition of Anorexia Nervosa (See Slepian Para [0023]).
This is a provisional nonstatutory double patenting rejection.
Instant Application 18/645,588
Reference Application 18/645,843
1. A method of increasing neuro-connectivity in an individual affected by a neuro-degenerative disease or a neurological disorder or a psychological disorder, said method comprising:
providing a personal electronic device to receive data related to the individual and the neuro-degenerative diseases or the neurological disorder or the psychological disorder;
implementing the digital therapy intervention plan for the individual carried out at least partially on the personal electronic device;
wherein the digital therapy intervention plan comprises at least one digital intervention configured for the interaction of the individual, the at least one digital intervention comprising: sensory inhibition, sensory substitution, sensory integration, or a combination thereof, wherein the digital therapy intervention plan further comprises modifying at least one sensory modality input on the personal electronic device during implementation of the digital therapy intervention plan, presenting it to the individual and monitoring the responses of the individual;
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input consists of: visual , auditory, and tactile;
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input, wherein the sensory substitution consists of:
visual to auditory and/or tactile;
auditory to visual and/or tactile; and
tactile to visual and/or auditory;
and wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities are selected from: visual, auditory, and tactile; and
administering medicinal agent before, during, after, or a combination thereof, said at least one digital intervention; and
adapting the digital therapy intervention plan based on the responses of the individual.
1. A method of improving immune function in an individual affected by an immune-related disorder, said method comprising:
the individual carrying out at least one digital intervention comprising:
sensory inhibition, sensory substitution, sensory integration, or a combination thereof;
wherein the at least one digital intervention is at least partially carried out on a personal electronic device, wherein the personal electronic device is configured to administer at least one sensory modality input selected from: visual, auditory, and tactile;
wherein the sensory inhibition comprises at least partial reduction of the at least one sensory modality input;
wherein the sensory substitution comprises at least partial replacement of the at least one sensory modality input with at least one other sensory modality input selected from: visual to auditory and/or tactile; auditory to visual and/or tactile; and tactile to visual and/or auditory; and
wherein the sensory integration comprises at least partial combination of at least two sensory modality inputs of the at least one sensory modality inputs.
3. The method of claim 1 wherein said digital intervention comprises: at least one psychological intervention, at least one cognitive intervention, at least one physical intervention, or a combination thereof.
3 in view of Slepian. The method of claim 1 wherein said at least one digital intervention comprises: at least one psychological intervention, at least one cognitive intervention, at least one physical intervention, or a combination thereof.
5. The method of claim 1 further comprising the personal electronic device being configured to onboard data for said individual wherein said data is selected from: personal, demographic, medical, biomarker information, medicinal agent intake and dosage regimen, geographic, environmental, lifestyle, health and wellbeing, biometric, behavioral, digital intervention related data, goal setting, medical considerations, preferences, availability, time constraints, scheduling, individual’s strengths and weaknesses, cultural considerations, communication channel preference, feedback from said individual, feedback from healthcare provider, or a combination thereof; for use in personalization of the digital therapy intervention plan.
5 in view of Slepian. The method of claim 2 further comprising transferring data for said individual wherein said data is selected from: personal, demographic, medical, biomarker information, medicinal agent intake and dosage regimen, geographic, environmental, lifestyle, biometric, behavioral, digital intervention related data, goal setting, medical considerations, health and wellbeing, preferences, availability, time constraints, scheduling, individual's strengths and weaknesses, cultural considerations, communication channel preference, feedback from said individual, feedback from healthcare provider, or a combination thereof, for use in personalization of said digital therapy intervention plan.
9. The method of claim 3 wherein said at least one psychological intervention is selected from: guided imagery, psychoeducation, psychotherapy, cognitive behavioral therapy, stress and anxiety management training, mindfulness-based interventions, body scanning training, sleep hygiene, fatigue training, acceptance and commitment therapy (ACT), dialectical behavior therapy (DBT), psychodynamic therapy, solution-focused brief therapy (SFBT), narrative therapy, pain therapy, addiction therapy, gestalt therapy, behavioral activation therapy, telepsychiatry and teletherapy or a combination thereof.
9 in view of Slepian. The method of claim 3 wherein said at least one psychological intervention is selected from: guided imagery, psychoeducation, psychotherapy, cognitive behavioral therapy, stress and anxiety management training, mindfulness-based interventions, body scanning training, sleep hygiene, fatigue training, acceptance and commitment therapy (ACT), dialectical behavior therapy (DBT), psychodynamic therapy, solution-focused brief therapy (SFBT), narrative therapy, pain therapy, addiction therapy, gestalt therapy, behavioral activation therapy, telepsychiatry and teletherapy or a combination thereof.
10. The method of claim 3 wherein said at least one cognitive intervention is selected from: navigation in a maze, spatial navigation, magic-7 training, memory enhancement techniques, attention training, problem-solving, sonification exercise, data visualization, geometric puzzles, shape and pattern matching, visual perception tasks, spatial reasoning games, face detection training, drawing game, focus training, reading training, or any combination thereof.
10 in view of Slepian. The method of claim 3 wherein said at least one cognitive intervention is selected from: navigation in a digital maze, spatial navigation, magic-7 training, memory enhancement techniques, attention training, problem-solving, sonification exercise, data visualization, geometric puzzles, shape and pattern matching, visual perception tasks, spatial reasoning games, face detection training, drawing game, focus training, reading training, or any combination thereof.
11. The method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy, swallow therapy, breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof.
11 in view of Slepian. The method of claim 3 wherein said at least one physical intervention is selected from: physiotherapy, voice therapy, speech therapy, swallow therapy, breathing training, saliva and drooling therapy, chewing therapy, facial expression training, tremor management, mobility training, freezing and rigidity exercises, tapping training, limb agility exercises, volume-duration-pitch training, training for freezing of gait, motor function therapy, dance therapy, handwriting training, balance exercises, postural stability training, strength training, stretching exercises, coordination training, metronome training, fine motor skills training, or a combination thereof.
19. The method of claim 1 wherein the interaction is selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof ; and wherein the adapting is executed in response to the interaction.
19 in view of Slepian. The method of claim 4 wherein said digital intervention comprises said individual interacting with said personal electronic device using any of the following means selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof.
24. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof.
24 in view of Slepian. The method of claim 1 wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof.
27. The method of claim 5 further comprising an adaptation plan, during the course of said digital therapy intervention plan, comprising: receiving said data; receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention, said at least one physical intervention, or a combination thereof; and generating an updated digital therapy intervention plan for said individual in response to the analyzing of said updated data.
27 in view of Slepian. The method of claim 3 further comprising an adaptation plan, during the course of said digital therapy intervention plan, comprising: receiving said data; receiving updated data in response to said at least one psychological intervention, said at least one cognitive intervention, said at least one physical intervention, or a combination thereof; and generating an updated digital therapy intervention plan for said individual in response to said updated data.
33. The method of claim 1 for treating, preventing, or alleviating symptoms in an individual affected by a neuro-degenerative disease.
37 in view of Slepian. The method of claim 1 for preventing, or alleviating symptoms in an individual affected by Parkinson's disease, Alzheimer's disease, and mild cognitive impairment (MCI).
(This is species of the corresponding genus.)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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This reference provides evidence that “sensory substitution” is a term of art. Cited on Applicant’s Information Disclosure Statement
US 20130194402 A1 (“Amedi”): Para [0041]: conversion of visual to auditory
US 20140079251 A1: Pertinent to sensory substitution
US 20150050626 A1: combination augmenting agent and neuronal stimulation
US 20180271427 A1: Hebb-Williams mazes and dyslexia
US 20220175285 A1: Hebb-Williams mazes and dyslexia
US 20230293048 A1: immersive environment for improving functional performance despite neurological impairment
US 20240062878 A1: Neuropsychopharmacology using virtual reality
US 11717639 B2: combinatorial digital therapeutic and drug
US 11903721 B1: digital therapeutic for mild cognitive impairment and dementia
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US-20240363019-A1, US-20240363227-A1, US-12512014-B2: by the same inventor, pertinent to potential double-patenting or non-statutory double patenting rejections.
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 Jesse P Frumkin whose telephone number is (571)270-1849. The examiner can normally be reached Monday - Saturday, 10-5 ET.
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/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 January 24, 2026