DETAILED ACTION
This action is a response to the filing on 8/11/2025. Examiner acknowledges the amendments made to claims 1, 5, 19, 27-29, and 3 and the cancellation of claim 2.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s amendments have overcome the previous 112 rejections.
Applicant’s arguments with respect to prior art rejections of claim(s) 1, have been considered but are moot because the new ground of rejection relies on a different combination of references. Applicant’s recent amendments have overcome US 2020/0402643 (Trees et al., hereinafter Trees); however, the new limitations are disclosed by US 2022/0139250 (Yanchurevich et al., hereinafter Yanchurevich) as shown in the rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 is dependent on cancelled claim 2. Thus, claim 2 is unclear. For the purposes of compact prosecution, claim 26 is being interpreted as dependent on claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 5, 9, 10, 11, 19, 24-35, and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0402643 (Trees et al., hereinafter Trees) in view of US 2022/0139250 (Yanchurevich et al., hereinafter Yanchurevich).
In regards to claim 1, 5, 33-35, and 37, Trees discloses a method that uses cognitive treatments that target immune-mediated and neuro-degenerative disorders of an individual (Title and abstract). Trees discloses that the conditions to be treated in a subject include Parkinson’s disease, Alzheimer’s disease, mild cognitive impairment, and multiple sclerosis (paragraphs 13, 14, 35, 36, 75, and 76), which are autoimmune disorders and immunodeficiency disorders, thus meeting the limitations of claims 33, 34, 35, and 37. Trees discloses the following steps:
providing a personal electronic device to receive data related to the individual (figure 2-3; paragraphs 78, 87, 115, 117, 195, 200-206; individual interacts with personal computing devices with interfaces such as iPhones, personal computers, laptop, etc. that administer stimulation);
generating a digital therapy intervention plan based on the data (paragraphs 87-91; generation of personalized treatment recommendation based on received data about individual);
implementing the digital therapy intervention plan for the individual; wherein the digital intervention plan comprises at least one digital intervention comprising sensory inhibition, sensory substitution, sensory integration, or a combination thereof (paragraph 115; an individual with the immune disorder is stimulated with more than one sensory modality input/sensory integration);
wherein the at least one digital intervention is at least partially carried out on a personal electronic device (figure 2-3; paragraphs 78, 87, 115, 117, 195, 200-206; individual interacts with personal computing devices with interfaces such as iPhones, personal computers, laptop, etc. that administer stimulation), wherein the personal electronic device is configured to administer at least one sensory modality input selected from: visual, auditory, and tactile (paragraphs 82, 115-117, 145 and 149-161);
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 (paragraphs 115 presenting a combination of visual, auditory, and/or tactile stimulation).
However, Trees does not mention the step of modifying the sensory modality inputs and adapting the digital therapy intervention plan based on the responses of the individual.
In a related area, Yanchurevich discloses the use of digital therapeutics with the aid of artificial intelligence (paragraph 23). Yanchurevich discloses the step of the individual carrying out at least one digital intervention comprising: sensory inhibition, sensory substitution, sensory integration, or a combination thereof (paragraphs 20, 33-59, and 69-88; user selects therapy that includes several sensory stimuli that can be considered as sensory inhibition or integration as part of a digital therapy intervention plan that can be considered as psychological intervention, physical intervention, or cognitive intervention carried out on a personal electronic device such as a laptop or smartphone).
Yanchurevich discloses in paragraphs 40 and 49 the adjustment of volume or speeds during the administration of visual and auditory stimuli. Based on the adjustment, the action can be taken as a partial reduction of one sensory modality. Decreasing the volume can be construed as reducing auditory modality stimuli while increasing volume can be considered as decreasing the input of the other sensory modalities, like the visual modality input, due to the decreased percentage contribution of the stimuli. In addition, paragraphs 70-73 disclose transferring data for the individual where the data includes health and biometric data, mental conditions and stress levels and analyzes degrees of improvement that can be achieved by the individual using machine learning techniques to optimize the fillable digital landscape and adapts and modifies the digital therapy intervention plan (change the presented augmented or virtual reality based on responses of the individual), which meets the limitations of claim 5. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Trees to modify the sensory modalities and adapt the digital intervention plan as taught by Yanchurevich in order to optimize the performance of the fillable digital landscape
In regards to claim 3, Trees and Yanchurevich disclose the limitations of claim 1. In addition, the therapies being provided in in paragraphs 113-118 can be considered as psychological, cognitive, or physical interventions.
In regards to claim 9, Trees and Yanchurevich disclose the limitation of claim 3. In addition, paragraph 117 discloses that psychoeducation, cognitive-behavioral therapy, and mindfulness training are some of the interventions implemented.
In regards to claim 10, Trees and Yanchurevich disclose the limitations of claim 3. In addition, paragraph 117 and 228 discloses the use of spatial navigation of a maze as one of the interventions implemented.
In regards to claim 11, Trees and Yanchurevich disclose the limitations of claim 3. In addition, paragraph 117 discloses that fine motor control training (considered as part of either fine motor skills training or motor function therapy) as one of the interventions implemented.
In regards to claim 19, Trees and Yanchurevich disclose the limitations of claim 1. In addition, paragraph 77, 141, and 220 disclose various methods ways for interaction with the device which include touch gesture, swipe gesture (motion gesture), and sensor-based interactions.
In regards to claim 24, Trees and Yanchurevich disclose the limitations of claim 1. In addition, Trees shows that the intervention can be implemented as a game (paragraph 150), instructional prompts (paragraphs 139 and 209-210), and virtual or augmented reality (paragraph 26 and 235-238).
In regards to claim 25, Trees and Yanchurevich disclose the limitations of claim 3. Trees states in paragraph 117 that duration of stimulation varies with paragraphs 141-143 giving duration examples of the stimuli/tasks that fall within the claimed range.
In regards to claim 26, Trees and Yanchurevich disclose the limitations of claim 1. Trees state that the PCTRs vary based on patient profiles (paragraph 112-114) and states various time courses of treatment which include a treatment plan lasting a few months or annually, which falls within the claimed range.
In regards to claim 27, Trees and Yanchurevich disclose the limitations of claim 5. In addition, paragraphs 111-125 show a closed loop feedback mechanism that shows the process of receiving data (initial setup), receiving updated data in response to the intervention (feedback), and generating an updated digital therapy intervention plan for the individual in response to the updated data (adaptation of tasks based on analysis at treatment engine).
In regards to claim 28, Trees and Yanchurevich disclose the limitation of claim 27, Trees further states in paragraph 118 changes in difficulty of intervention to reap maximal cognitive benefits.
In regards to claim 29, Trees and Yanchurevich disclose the limitation of claim 1. In addition, Tree notes in in paragraph 26 and 237-239 that the method is implemented with a virtual reality system, which would require a virtual reality set (note that applicant has not disclosed what constitutes the virtual reality set). Tree also uses smartphones as noted to the in paragraphs 203 and 206 as additional devices. Tree also discloses the use of feedback to the individual via the computing device (paragraph 155) and the navigation tools in a virtual environment (paragraphs 80 and 237-239) which would require data transfer between additional device and the individual or the personal electronic device.
In regards to claim 30, Trees and Yanchurevich disclose the limitations of claim 29. In addition, changes in perspective in the virtual environment during the navigation task as noted in paragraphs 237-239 can be considered as providing real-time feedback to the individual based on gathered data and interaction or providing an output a signal to the individual.
In regards to claim 31, Trees and Yanchurevich disclose the limitation of claim 29. Yanchurevich discloses the use of a digital scapefor mind integration. Of note is paragraph 38 that discloses several body worn health monitoring devices that can be considered as wearable fitness trackers or remote patient monitoring systems due to their ability to monitor a user. Yanchurevich states this eliminates the problems with self-report inventories. Thus, it would be obvious to one of ordinary skill in the at art, before the filing date of the claimed invention, to modify the method of Trees and Yanchurevich to use the health monitoring system of Yanchurevich to eliminate problems associated with self-reported inventory.
In regards to claim 32, Trees and Yanchurevich disclose the limitations of claim 29. In addition, because the personal device as noted in claim 1 and virtual reality system implements the sensory integration, the limitations are met.
In regards to claim 38, Trees and Yanchurevich disclose the limitations of claim 1. As noted in paragraph 115, a combination of visual, auditory, and/or tactile stimulation is presented in the intervention. If there is more than one stimulus presented the second or third stimulus administered simultaneously can be considered as a conditioning stimulus. Another way to interpret the claim would be the initial stimulus (conditioning stimulus) and the feedback response (the intervention) in paragraphs 114-118 during a treatment session can be considered as being administered together as Applicant has not specified what constitutes being “administered together” entails (administered in the same treatment session simultaneously or sequentially can be considered as administered together).
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0402643 (Trees et al., hereinafter Trees) US 2022/0139250 (Yanchurevich et al., hereinafter Yanchurevich) as applied to claim 3 above, and further in view of US 2017/0113046 (Fried et al., hereinafter Fried).
In regards to claims 10 and 12, Trees and Yanchurevich disclose the limitations of claim 3 but do not show the navigation of a digital maze. In a related area, Fried discloses system and methods for restoring cognitive function (Title and abstract). Fried specifically works on restoring function on patients with memory and learning impairments (paragraphs 52 and 113), a type of cognitive impairment, and analyzes the impairments using Morris water maze and Barnes maze (paragraphs 100, 113, 185, and 303) with some version of the mazes being constructed in virtual reality which allows for measuring multiple types of memory (paragraph 355). Usage of virtual reality to implement the maze would make it a digital maze. Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Trees and Yanchurevich to use digital versions of the Morris water maze and Barnes maze as taught by Fried in order to measure multiple types of memory
Allowable Subject Matter
Claim 36 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claim 36, the prior art of record does not teach or suggest a method, as claimed by Applicant, that implements the claimed method on an individual with an immunodeficiency disorder selected from severe combined immunodeficiency (SCID), DiGeorge syndrome, hyperimmunoglobulin E syndrome (Job's syndrome), common variable immunodeficiency (CVID), chronic granulomatous disease (CGD), Wiskott-Aldrich syndrome (WAS), autoimmune lymphoproliferative syndrome (ALPS), hyper IgM syndrome, leukocyte adhesion deficiency (LAD), NF-ĸB essential modifier (NEMO) mutations, selective immunoglobulin A deficiency, X-linked agammaglobulinemia (XLA), X-linked lymphoproliferative disease (XLP), and ataxia-telangiectasia.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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