DETAILED ACTION
Status
This communication is in response to the application filed on 31 May 2024. Claims 1-30 are pending and presented for examination.
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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 31 May 2024 and 11 March 2025 were filed after the mailing date of the application on 31 May 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Examiner Notes
Since the Examiner has struggled with trying to understand what is, and/or is not, either an external activity and/or an internal activity, it is noted that the specification indicates:
a/the first and/or second “modules selected from the group consisting of a voluntary skeletal muscle exercise module, a vagal nerve stimulation module, an aerobic exercise module, and a relaxation module” (at Applicant ¶¶ 0005-0007 as published).
“the vagal nerve stimulation module comprises at least one instruction selected from the group consisting of sense stimulation instructions for sight, sound, touch, taste, and smell” and “the vagal nerve stimulation module comprises one or more sense stimulation instructions for touch, and the one or more sense stimulation instructions for touch include one or more instructions for abdominal breathing, controlling rate of breathing, cold massage, coughing, and skin massage” (at Applicant ¶ 0009 as published, with similar at ¶ 0143)
“early external activity for the early state cancer patients may be different from the late external activity for the late stage cancer patients” (at Applicant ¶ 0062 as published).
“the late external activity includes touching a screen with a finger or a heel, and deep breathing…. In additional embodiments, the late external activity includes lifting a head while lying down, and raising a hand or leg while lying down …. In further embodiments, the late external activity includes grabbing phone while lying down, turning a head while lying down” (at Applicant ¶ 0063 as published).
“external activities may comprise of voluntary skeletal muscle exercises or aerobic exercises. In certain embodiments, internal activities may comprise of mediation [sic – understood to be a typographical error that should be “meditation”] exercises, breathing exercises, or massage exercises” (at Applicant ¶ 0141 as published).
“the voluntary skeletal muscle exercise module compromise one or more first instructions for gravity exercise sessions, anti-gravity exercise sessions, lying down exercise sessions, and sitting exercise sessions (FIG. 17). In certain embodiments, the gravity exercise sessions may comprise one or more instructions for finger taps and heel taps (FIG. 18). In certain embodiments, the finger taps exercise may instruct the subject to lie down and touch the electronic device screen with their finger for about 5, 4, 3, 2, or 1 minute, then rest for 3, 2, or 1 minute by deep breathing. In addition, the electronic device may provide sound feedback when the subject inputs the screen touch. In certain embodiments, the heel taps exercise may instruct the subject to lie down and touch the electronic device screen with their heels for about 5, 4, 3, 2, or 1 minute, then rest for 3, 2, or 1 minute by deep breathing” (at Applicant ¶ 0146 as published, with similar or further indications at 0147-0148).
“an exemplary internal activity use flow of a digital application of the meditation, breathing, and massage modules in the present disclosure. The subject may be instructed in the internal activity modules of the digital application to perform breathing exercises, mediation exercises, or massage exercises” (at Applicant ¶ 0151 as published)
“the external activity module may be divided into three levels, which is exemplary, and may be divided into two or more levels. In the present disclosure, the internal activity module has only one level (that is, the level is not divided), which is exemplary, and may be divided into a plurality of levels like the external activity module” (at Applicant ¶ 0170 as published).
“the external activity module may include a Finger tap module as a first level module…. the external activity module may include a Head turning module and a Hand gripping module as a second level module.... In addition, the external activity module according to the present disclosure may include a Lag [sic – understood to be a typographical error that should be “Leg”] lifting module, a Head lifting module, a Screen touch module, and an Arm shaking module as a third level module” (at Applicant ¶ 0171 as published).
“The internal activity module may include breathing exercises, auditory stimulation exercises, and vagal nerve sensory stimulation exercises. All internal activity modules can be performed by a user sitting down while fixing the digital apparatus to the cradle. The breathing activity module may instruct the user to take deep breaths sufficiently” (at Applicant ¶ 0172 as published).
“the external activity instructions may be provided first, and then the internal activity instructions may be provided. However, this is exemplary, and the sequence of external activity instructions and internal activity instructions may be changed in various ways. For example, the external activity instructions may be provided after the internal activity instructions, or the internal activity instructions and external activity instructions may be provided alternately. The concept of the sequence of external activity instructions and internal activity instructions may be applied to other sections and other subsections as well” (at Applicant ¶ 0176 as published).
“the internal activity instructions comprise breathing exercises, auditory stimulation exercises and vagal nerve stimulation exercises” (at Applicant ¶ 0545 as published).
In summary, it appears that internal activities include vagal nerve stimulation designed or intended for a sense (i.e., “sense stimulation instructions for sight, sound, touch, taste, and smell”), and external activities include voluntary skeletal muscle exercise such as aerobic exercise, hand, head, or leg lifts, grabbing, breathing, and/or touching a screen. However, both internal and external activities include touching (e.g., touching a screen) and breathing exercises.
Claim Interpretation
The Examiner notes that parent independent claim 1 recites “a predetermined period comprising a plurality of sections”. Applicant ¶ 170 (as submitted, 0168 as published) indicates a “period” as being a period of time (such as days), where the “section” may then be a shorter period of time (Id.). However, “section”, “sections”, and “subsections” also are described using the term “period” (i.e., “each of a plurality of subsections included in one section may be the same period” at 171 as submitted, 0169 as published).
The Examiner notes that claim 1 recites “a digital program for treating cancer cachexia”; however, the claims only require providing of modules for external or internal activity and any “treating [of] cancer cachexia” is merely intended or desired. It is noted that virtually any game provided on a computer, such as solitaire, minesweeper, etc. from decades back (the Examiner is/was familiar with the indicated games as basic inclusions in software packages or suites in the mid-1990s) required both external and internal activity exercises (e.g., pressing direction and/or selection keys, and/or mentally planning what to do in the game(s)). Therefore, the “treating cancer cachexia” is indicated as a/an desired or intended use/result that at least MPEP § 2103(I)(C) indicates may be granted little if any patentable weight. This is to say that although the claims provide a module for external and/or internal activity, whether that module is intended, designed, or actually does treat cancer cachexia is regarded as having little if any patentable weight.
The Examiner notes that claim 24 recites “the plurality of external activity modules for promoting MGF/IGF-1 secretion and adiponectin secretion”, where this explicitly states the goal or intended result (i.e., increased MGF/IGF-1 and/or adiponectin secretion). The only description of this is that “methods and systems of the present disclosure increase insulin-like growth factor 1 (IGF1) and/or a splice variant of IGF-1 called mechano growth factor (MGF) levels (IGF1/MGF level), for example, using voluntary skeletal muscle exercise modules and/or digital instructions for a patient's diet, which can (i) inhibit myostatin and prevent muscular atrophy associated with proteolysis, and/or (ii) activate insulin receptor substrate 1 (IRS1)-PI3K-AKT signaling and AKT to promote proteosynthesis (see Applicant ¶ 0061 as published). At least MPEP § 2103(I)(C) indicates may be granted little if any patentable weight since the claim is to the desired goal or intended result (rather than an actual activity. Since there is no other support or description of exercises or activity, claim 24 is interpreted as instructing any voluntary skeletal muscle exercise.
The Examiner notes that claim 25 recites “the one or more first modules comprises the internal activity module for reducing inflammation”, where the description related to this indicates “the vagal nerve stimulation module comprises one or more first instructions to reduce inflammation in the subject. In some embodiments, the one or more first modules comprise the vagal nerve stimulation module, and the vagal nerve stimulation module comprises at least one instruction selected from the group consisting of sense stimulation instructions for sight, sound, touch, taste, and smell” (see Applicant ¶ 0009 as published). At least MPEP § 2103(I)(C) indicates may be granted little if any patentable weight since the claim is to the desired goal or intended result (rather than an actual activity. Therefore, claim 25 is interpreted as any vagal nerve stimulation exercise being instructed.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-30 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “to provide … one or more first modules selected from the group consisting of external activity modules and an internal activity module”. The Examiner has thoroughly reviewed the specification as indicated above at the Examiner Notes section. As noted above, an external activity module apparently includes instructing for voluntary skeletal muscle exercise such as aerobic exercise, hand, head, or leg lifts, grabbing, breathing, and/or touching a screen. An internal activity module includes instructing for “vagal nerve stimulation” designed or intended for a sense (i.e., “sense stimulation instructions for sight, sound, touch, taste, and smell” – see at least Applicant ¶ 0009 (quoted) and ¶ 0143 as published). Applicant ¶¶ 0009 and 0143 illustrate this as instructions “to view … figures” (or “photos”) (for sight), “to hear one or more sounds to cause horror or relaxation” (for sound), “instructions for abdominal breathing, controlling rate of breathing, cold massage, coughing, and skin massage” (for touch), “instructions to eat food to stimulate digestive glands in the subject” (for taste), and “instructions to stimulate digestive glands and/or to relax” (for smell).
Applicant does not appear to actually describe what “vagal nerve stimulation” is – Applicant merely uses the term as above, indicating instructions a/the person should follow or perform.
However, at least Vagus Nerve (from the Cleveland Clinic), Schwartz, Terry, Boveja, and Libbus (see the related prior art not relied on below) – as an arbitrary sampling of literature – all indicate that “vagal nerve stimulation” (or vagus nerve stimulation) is performed by providing an electrical stimulation signal to an inserted electrode to stimulate the nerve. (The Examiner notes that there were approximately 80 of just US patent documents returned in a basic search, apparently all indicating a similar view of what vagal nerve stimulation means.)
Therefore, it appears that Applicant is using the term ““vagal nerve stimulation” entirely differently than the general healthcare or medical community. As such, Applicant has not acted as a lexicographer to define what they mean by “vagal nerve stimulation”, and the plain meaning of the term appears to conflict with the use of the term in Applicant’s disclosure, specification, and claims. Therefore, what is apparently meant by internal activity instructions (as included/provided by an “internal activity module”) and particularly “vagal nerve stimulation” is not reasonably discernable and the term(s) are considered to be indefinite.
Claims 2-30 depend from claim 1, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 2-30 are also indefinite. Particularly, claim 20 recites “wherein the internal activity instructions comprise breathing exercises, auditory stimulation exercises and vagal nerve stimulation exercises”, such that the internal activity module, the internal activity instructions, and “vagal nerve stimulation” are indefinite.
Claim 1 recites to “provide … one or more first modules selected from the group consisting of a plurality of external activity modules and an internal activity module, each of the one or more first modules comprising one or more first instructions for the subject to follow, wherein the one or more first instructions are selected from a plurality of external activity instructions of the plurality of external activity modules and a plurality of internal activity instructions of the internal activity module, wherein the processor provides the one or more first modules for a pre-determined period comprising a plurality of sections, the plurality of sections having different combinations of external activity modules from among the plurality of external activity modules”. Therefore, it appears on its face that claim 1 only requires one module be provided, and that one module may be either an external activity module or an internal activity module. Per the phrasing of claim 1 – at the final wherein phrase – the sections must then have external activity modules. But then dependent claim 2 recites that “each of the plurality of sections has the internal activity module”.
As such, claim 1 could apparently also be interpreted as “the group” consisting of providing BOTH an external activity module AND an internal activity module – rather than the claim indication that only one of external or internal activity modules is provided.
If claim 1 is interpreted as only requiring the providing of either an external or an internal activity module, then claim 2 apparently cancels the requirement for an external activity module and only requires an internal activity module. However, if claim 1 is interpreted as requiring both an external and an internal activity module, then claim 2 apparently does not further limit since the internal activity module is already required.
Further, claim 9 depends from claim 2 (through or via claims 3 and 4) and recites that a section time period “comprises a subsection having only the first level of external activity module” – which apparently requires that an external module be present.
Therefore, the Examiner is uncertain whether the claims should be interpreted as requiring only one module that is EITHER an external activity module or an internal activity module, or if the claim should be interpreted as requiring BOTH an external and an internal activity module. It appears that regardless of the interpretation, some dependent claims either cancel at least one limitation from at least one parent claim, or fail to provide a further limitation to an element of a parent claim.
The Examiner is interpreting the claims as only requiring one of either an external activity module or an internal activity module.
Claims 2-30 depend from claim 1, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 2-30 are also indefinite.
Claim 12-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites “wherein the external activity instructions comprise gravity exercises, active exercises and anti-gravity exercises”. The Examiner notes that the modules are “activity” modules, so it would appear that literally any activity that is instructed by the module is, by definition an “active exercise”. Furthermore, there does not appear to be any choice other than either a gravity or anti-gravity exercise, if there is an exercise. Applicant’s description indicates “gravity exercise sessions may comprise one or more instructions for finger taps and heel taps” (Applicant ¶ 0146 as published), and “anti-gravity exercise sessions comprise one or more instructions for head lifting, raising up hand, and raising up leg” (Id.) – as indicated at dependent claim 13. There does not appear to be any difference between the gravity and anti-gravity exercises – they both are merely using gravity to perform an exercise!
Claims 13-19 depend from claim 12, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 13-19 are also not further limiting. Although claims 13-19 indicate various exercises, all the examples appear to be gravity and/or anti-gravity exercises, no matter how the terms are interpreted.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to an apparatus, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a digital apparatus for treating cancer cachexia in a subject, the apparatus comprising: a memory storing a digital program for treating cancer cachexia; and a processor configured to execute the digital program to: provide, by the digital apparatus to the subject, one or more first modules selected from the group consisting of a plurality of external activity modules and an internal activity module, each of the one or more first modules comprising one or more first instructions for the subject to follow, wherein the one or more first instructions are selected from a plurality of external activity instructions of the plurality of external activity modules and a plurality of internal activity instructions of the internal activity module, wherein the processor provides the one or more first modules for a pre- determined period comprising a plurality of sections, the plurality of sections having different combinations of external activity modules from among the plurality of external activity modules.
The dependent claims (claims 2-30) appear to be encompassed by the abstract idea of the independent claims since they merely indicate the use of an internal and/or external activity module (claims 2, ), relative levels of activity (claims 3, 4, 8, 9), and relative time periods (a period, section, subsection, unit period, etc.) (claims 4, 5, 6, 7, 8, 21-23), selecting the instructions based on user input (claim 10), repeating activities (claim 11), instructing to perform gravity, anti-gravity, and/or active exercises (claim 12), what the instructed activities comprise (claims 13-20, 24), the intended goal of the activity (claims 24-25), sensing adherence to the instructions and providing a second module based on adherence information (claim 26), providing a second module selected from external and internal activity modules (claim 27), if not all scheduled modules are performed, providing a scheduled first module (claim 28), receiving selection of a module when all scheduled modules have been performed and providing the module (claim 29), and/or provide a tutorial when an additional (second) module is provided the first time (claim 30).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of providing instructions to perform certain activities; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the certain methods of organizing human activity (e.g. … commercial or legal interactions such as agreements, contracts, legal obligations, advertising, marketing or sales activities/behaviors, or business relations; and/or managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions) grouping(s) of subject matter.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are using a digital apparatus, the apparatus comprising: a memory storing a digital program; and a processor configured to execute the digital program to: provide, by the digital apparatus to the subject, one or more first modules (at claim 1) and/or second or additional modules (at various dependent claims). These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant ¶ 0108 (as published) indicates the “hardware configuration of the digital apparatus for treating cancer cachexia” is a generic or general purpose computer, such as, or including, “Various examples of the digital apparatus include a desktop computer, a laptop computer, a tablet computer, a server computer, a server system, a wearable device such as a smart watch, and other computing devices”.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
NOTICE
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-14, 18-29 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell et al. (U.S. Patent Application Publication No. 2019/0209777, hereinafter O’Connell) in view of Del Fabbro, E., Combination therapy in cachexia. Ann Palliat Med 2019;8(1):59-66. doi: 10.21037/apm.2018.08.05, downloaded 1 January 2026 (hereinafter Del Fabbro).
Claim 1: O’Connell discloses a digital apparatus … in a subject, the apparatus comprising:
a memory storing a digital program (see O’Connell at least at, e.g., ¶¶ 0121, “The computer system 1400 includes a server 1402, a CPU 1403, a memory 1404, a storage unit 1405, biometric sensors 1406, and a communication interface 1407”, 0187, “The server 601 includes a central processing unit 602, which can be a single core or multi core processor, or a plurality of processors for parallel processing. The server 601 also includes: memory 603, such as random-access memory, read-only memory, and flash memory; electronic storage unit 604, such as a hard disk; communication interface 605, such as a network adapter, for communicating with one or more other systems; and peripheral devices 606, such as cache, other memory, data storage, and electronic display adapters. The memory 603, storage unit 604, interface 605 and peripheral devices 606 are in communication with the CPU 602 through a communication bus, such as a motherboard”; citation hereafter by number only); and
a processor configured to execute the digital program (0121, “The computer system 1400 includes a server 1402, a CPU 1403, a memory 1404, a storage unit 1405, biometric sensors 1406, and a communication interface 1407”) to:
provide, by the digital apparatus to the subject, one or more first modules selected from the group consisting of a plurality of external activity modules and an internal activity module, each of the one or more first modules comprising one or more first instructions for the subject to follow, wherein the one or more first instructions are selected from a plurality of external activity instructions of the plurality of external activity modules and a plurality of internal activity instructions of the internal activity module (0121, “a computer system 1400 programmed or otherwise configured to allow monitoring of a biometric of a subject by biometric sensors 1406 or external biometric devices 1410, presentation of an instructional exercise by instructional exercise module 1408”),
wherein the processor provides the one or more first modules for a pre-determined period comprising a plurality of sections, the plurality of sections having different combinations of external activity modules from among the plurality of external activity modules (0063, “At various periods of time, the treadmill accelerates and the incline rises, until the subject reaches the maximum sustained effort. The measured heart rate of the subject at the maximum sustained effort is the maximum heart rate of the subject”, 0073-0081: 0073-0074 listing various time periods that may be used, from “about 5 minutes” to “at least about 6 hours”, where although this indicates timing for a “dose of hormone”, it is also in response to “measuring the glucose level of the subject during the state of physical exercise” at 0075, and “an action is performed to restore the glucose level to within the critical glucose range. In some embodiments, the glucose level is below the critical glucose range, and the action is the consumption of a carbohydrate by the subject” at 0076, and “an exercise instruction of the disclosure is based upon a time of day. Non-limiting examples of times of day include early morning, mid-morning, afternoon, and evening. In some embodiments, the exercise instruction of the disclosure is based upon a diet consumed by the subject. In some embodiments, the exercise instruction of the disclosure is based upon an activity of the state of physical exercise” at 0081).
O’Connell, however, does not appear to explicitly disclose the exercises being for the intended use of for treating cancer cachexia. Where O’Connell teaches “methods, systems, algorithms, computer programs, … for exercise guidance and instruction specific to diabetes relief and management, and the slowing or reducing a likelihood of developing a diabetic condition” (O’Connell at 0037) and that “Non-limiting examples of long-term complications due to diabetes include damage to blood vessels, … [where d]amage to blood vessels of the nerves, known as diabetic neuropathy, can result in numbness, tingling, pain, altered pain sensation, leading to damage of the skin, and painful muscle wasting and weakness” (O’Connell at 0044), O’Connell is treating the same wasting as cachexia (see the prior art not relied on below). Although the cause of wasting or cachexia being cancer is not disclosed, and further that this appears to be merely an intended use that may be granted little if any weight, Del Fabbro teaches that “Ken Fearon recognized [in 2008, see FN 1,] that … the role of co-morbid conditions such as age-related sarcopenia and immobility in contributing to muscle-wasting was appreciated, providing justification for including physical activity and nutritional support in formulating comprehensive cachexia therapy for the ‘whole patient’. Pre-clinical research elucidating the complex molecular mechanisms of cancer cachexia revealed additional support for the inclusion of specific individual interventions into multimodality treatment strategies and increased susceptibility for cachexia because of genetic variation.” (Del Fabbro at 59). Therefore, the Examiner understands and finds that to instruct for exercise related to cancer cachexia is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to treat cancer cachexia in order to formulate comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the cachexia treatment of Del Fabbro in order to instruct for exercise related to cancer cachexia in order to formulate comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to instruct for exercise related to cancer cachexia is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to treat cancer cachexia in order to formulate comprehensive cachexia therapy for the whole patient as explained above.
Claim 2: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein each of the plurality of sections has the internal activity module (O’Connell at 0117, “a user can be performing a running exercise in an augmented reality landscape and experiences a trending pattern of blood glucose readings (e.g., up or down at different rates of change) from a continuous blood glucose monitor. The landscape of the augmented reality of the user can change to increase or decrease the level of effort for navigation depending on the desired impact on the trending blood glucose level”, 0137, “The program can present the user with a series of options, for example, selectable icons…. The user can select any of the icons …. Selecting a selectable icon can be performed, for example, by clicking a clickable icon, dragging and dropping an icon, sliding a selectable icon, or by voice recognition of an icon to a command”, both paragraphs indicating that pictures and/or glucose values are being viewed by the user and therefore constituting sight exercises per the light of Applicant’s specification).
Claim 3: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 2, wherein each of the plurality of external activity modules has a level from among a plurality of levels, and wherein a section from the plurality of sections has a combination of external activity modules with a higher average level than that of a subsequent section (0053, “.a collection of exercises is pre-selected to achieve the desired diabetes metrics listed above. Each suggested exercise is pre-selected to meet at least one of the following criteria: be performed in a heart rate zone from 50% to 100% of a maximum heart rate and correlating exertion level that does not cross the anaerobic threshold and does not stimulate the raising of glucose levels”).
Claim 4: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 3, but does not appear to explicitly disclose wherein each of the plurality of external activity modules has a level from among three levels, and the predetermined period comprises three sections, wherein a first section has a first level and a second level external activity modules, a second section has the first level, the second level, and a third level external activity modules, and a third section has the second level and the third level external activity modules. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to use three sections, three levels, subsections, and unit periods so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 5: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 4, but does not appear to explicitly disclose wherein each of the plurality of sections comprises a plurality of subsections, the plurality of sub- sections having different combinations of first instructions of the one or more first modules. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to use three sections, three levels, subsections, and unit periods so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 6: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 5, but does not appear to explicitly disclose wherein each of the plurality of sub- sections comprises unit periods, and a number of first instructions for a unit period in a subsection is larger than that in a preceding subsection within a same section. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to use three sections, three levels, subsections, and unit periods so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 7: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 4, but does not appear to explicitly disclose wherein each of the plurality of sections comprises unit periods, and a number of first instructions of the one or more first modules for a unit period is equal or larger than that for a preceding unit period within a same section. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to use three sections, three levels, subsections, and unit periods so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 8: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 3, but does not appear to explicitly disclose wherein each of the plurality of sections comprises unit periods, and wherein the processor is configured to provide an external activity instruction having a lower level earlier than that having a higher level during a unit period. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to use three sections, three levels, subsections, and unit periods so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 9: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 4, but does not appear to explicitly disclose wherein the first section further comprises a subsection having only the first level external activity module. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to use three sections, three levels, subsections, and unit periods so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to use three sections, three levels, subsections, and unit periods would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 10: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein the one or more first instructions are selected from among the plurality of external activity instructions of the plurality of external activity modules and/or the plurality of internal activity instructions of the internal activity module based on an input from the subject (O’Connell at 0082, “[a] subject can receive exercise instruction for safe and effective activities … [and] the subject inputs into the system a choice of exercise to perform, and receives instruction based on the subject's choice of exercise”).
Claim 11: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, but does not appear to explicitly disclose wherein the providing of one or more modules repeats predetermined number of times. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to repeat modules would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to repeat modules so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to repeat modules would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 12: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein the external activity instructions comprise gravity exercises, active exercises and anti-gravity exercises (O’Connell at 0129, “a user performing or instructed to perform weight lifting or resistance training exercises”).
Claim 13: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 12, wherein the instructions for the gravity exercises include one or more instructions for finger tap exercises for a subject lying down, the instructions for the active exercises include one or more instructions for head turning exercises and hand gripping exercises for a subject sitting down, and the instructions for the anti-gravity exercises include one or more instructions for leg lifting exercises and head lifting exercises for a subject lying down, and screen touch exercises and arm shaking exercise for a subject sitting down (O’Connell at 0082, “[a] subject can receive exercise instruction for safe and effective activities … [and] the subject inputs into the system a choice of exercise to perform, and receives instruction based on the subject's choice of exercise” – subject inputting a choice indicating finger tapping).
Claim 14: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 13, wherein the one or more instructions for finger tap exercises represent exercises to tap a randomly displayed animation on a screen of the digital apparatus device (O’Connell at 0082, “[a] subject can receive exercise instruction for safe and effective activities … [and] the subject inputs into the system a choice of exercise to perform, and receives instruction based on the subject's choice of exercise” – the subject matter of what was output to the user having no functional relationship to the tapping as an exercise; therefore, little if any weight may be granted to a “displayed animation” being tapped/selected as input, see, e.g., MPEP § 2111.05).
Claim 18: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 13, wherein the one or more instructions for screen touch exercises represent exercises to pick up the digital apparatus and move a position of the digital apparatus device to find an object which appears on a screen of the digital apparatus (O’Connell at 0168, 0233, 0237-0238, weight lifting – the subject matter of what was lifted having no functional relationship to the picking up as an exercise and the goal or intended result of finding an object; therefore, little if any weight may be granted to picking up the apparatus and finding an object, see, e.g., MPEP § 2111.05).
Claim 19: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 13, the one or more instructions for arm shaking exercise represent exercises to move an object displayed on a screen of the digital apparatus across the screen with an index finger of the subject, a tip of the index finger is detected by a front camera of the digital apparatus to determine a position on the screen corresponding to the detected tip of the index finger (O’Connell at 0137, “dragging and dropping an icon”).
Claim 20: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein the internal activity instructions comprise breathing exercises, auditory stimulation exercises and vagal nerve stimulation exercises (O’Connell at 0117, “a user can be performing a running exercise in an augmented reality landscape and experiences a trending pattern of blood glucose readings (e.g., up or down at different rates of change) from a continuous blood glucose monitor. The landscape of the augmented reality of the user can change to increase or decrease the level of effort for navigation depending on the desired impact on the trending blood glucose level”, 0137, “The program can present the user with a series of options, for example, selectable icons…. The user can select any of the icons …. Selecting a selectable icon can be performed, for example, by clicking a clickable icon, dragging and dropping an icon, sliding a selectable icon, or by voice recognition of an icon to a command”, both paragraphs indicating that pictures and/or glucose values are being viewed by the user and therefore constituting vagal nerve stimulation per the light of Applicant’s specification).
Claim 21: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, but does not appear to explicitly disclose wherein each of the plurality of subsections comprises unit periods, and first instructions for a unit period include one or more of the external activity instructions and one or more of the internal activity instructions. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to repeat modules would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to repeat modules so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to repeat modules would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 22: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 20, but does not appear to explicitly disclose wherein first instructions for a unit period include equal or larger number of external activity instructions than internal activity instructions. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to repeat modules would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to repeat modules so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to repeat modules would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 23: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, but does not appear to explicitly disclose wherein each of the one or more first instructions are provided with a break after a preceding first instruction is finished. O’Connell, though, teaches pre-selected exercises with correlated exertion levels (O’Connell at 0053), including based on the subject’s level of fitness (O’Connell at 0054), and a wide variety of time periods such as 5 minute periods, 30 minute periods, 60 minute periods (O’Connell at 0074) and “times of day [that] include early morning, mid-morning, afternoon, and evening” (O’Connell at 0081) based on the state of physical exercise (O’Connell at 0075-0076 and 0079-0081) – indicating levels, periods, sections, subsections, and unit periods where each has a different level, and the levels can progress. The various time periods and activity levels can be selected from the finite list of options regarding the time periods and levels, each apparently having the same expectation of success. Therefore, the Examiner understands and finds that to repeat modules would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell with the treatments of Del Fabbro in order to repeat modules so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient.
The rationale for combining in this manner is that to repeat modules would be obvious to try since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success so as to provide exercise activities as a formulated comprehensive cachexia therapy for the whole patient as explained above.
Claim 24: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein the one or more first modules comprises the plurality of external activity modules for promoting MGF/IGF-1 secretion and adiponectin secretion (O’Connell at 0168, 0233, 0237-0238, weight lifting as voluntary skeletal muscle exercise – see Applicant ¶ 0061 as published).
Claim 25: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein the one or more first modules comprises the internal activity module for reducing inflammation (O’Connell at 0137, “The program can present the user with a series of options, for example, selectable icons…. The user can select any of the icons …. Selecting a selectable icon can be performed, for example, by clicking a clickable icon, dragging and dropping an icon, sliding a selectable icon, or by voice recognition of an icon to a command”, constituting sight exercises per the light of Applicant’s specification indicated as internal activity).
Claim 26: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein the digital apparatus comprises a sensor sensing adherence by the subject to the first instructions of the one or more first modules, and the digital apparatus transmits adherence information, based on the adherence, to a server, and receives the one or more second modules from the server based on the adherence information (O’Connell at 0073-0081, the exercises provided based on sensing of glucose, activity level, heart rate, etc. as second and adjusted activities).
Claim 27: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein the processor further configured to execute the digital program to: provide, by the digital apparatus to the subject, one or more second modules selected from the group consisting of the plurality of external activity modules and the internal activity module, the one or more second modules comprising one or more second instructions for the subject to follow (O’Connell at 0073-0081, the exercises provided based on sensing of glucose, activity level, heart rate, etc. as second and adjusted activities).
Claim 28: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, wherein the processor further configured to: determine whether the one or more first modules have been performed according to a predetermined schedule after checking execution of the digital program; and if not all of the one or more scheduled first modules have been performed, provide scheduled first modules that are not performed (O’Connell at 0073-0081, the exercises provided based on sensing of glucose, activity level, heart rate, etc. and therefore performed, 0082, “[a] subject can receive exercise instruction for safe and effective activities … [and] the subject inputs into the system a choice of exercise to perform, and receives instruction based on the subject's choice of exercise”).
Claim 29: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 1, the processor further configured to: determine whether the one or more first modules have been performed according to a predetermined schedule after checking execution of the digital program; and if all of the one or more scheduled first modules have been performed, receive an input from the subject to select one or more additional instructions selected from the group consisting of the external activity instructions and the internal activity instructions (O’Connell at 0073-0081, the exercises provided based on sensing of glucose, activity level, heart rate, etc. as second and adjusted activities, 0082, “[a] subject can receive exercise instruction for safe and effective activities … [and] the subject inputs into the system a choice of exercise to perform, and receives instruction based on the subject's choice of exercise”).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell in view of Del Fabbro in further view of Walker (U.S. Patent No. 11,389,694).
Claim 15: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 13, but does not appear to explicitly disclose wherein the one or more instructions for head turning exercises represent exercises to turn a head of the subject clockwise and/or counterclockwise at a predetermined angle from a reference plane. Walker, though, teaches an exercise apparatus for “physical therapy, body building, strengthening, toning, and the like” (Walker at column:lines 8:16-39, quoting 38-39), including “A rotational resistance exercise apparatus [that] resists the rotation of a person's head. A person's head has an axis of rotation about which the head can turn left and right” (Walker at 14:2-28), and includes hand grip exercising capabilities (Walker at 31:51-56, 32:34-41). Therefore, the Examiner understands and finds that to recommend or provide instructions for using the machine for physical therapy or treatment, including turning a subject’s head, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide exercises in a formulated, comprehensive therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell in view of Del Fabbro with the exercising of Walker in order to instruct for exercise, including turning a subject’s head, as part of a formulated, comprehensive therapy for the whole patient.
The rationale for combining in this manner is that to recommend or provide instructions for using the machine for physical therapy or treatment, including turning a subject’s head, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide exercises in a formulated, comprehensive therapy for the whole patient as explained above.
Claim 16: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 13, but does not appear to explicitly disclose wherein the one or more instructions for hand gripping exercises represent exercises to grip a fist of the subject at a rate matching a displayed animation on a screen of the digital apparatus device. Walker, though, teaches an exercise apparatus for “physical therapy, body building, strengthening, toning, and the like” (Walker at column:lines 8:16-39, quoting 38-39), including “A rotational resistance exercise apparatus [that] resists the rotation of a person's head. A person's head has an axis of rotation about which the head can turn left and right” (Walker at 14:2-28), and includes hand grip exercising capabilities (Walker at 31:51-56, 32:34-41). Therefore, the Examiner understands and finds that to recommend or provide instructions for using the machine for physical therapy or treatment, including hand grip exercising, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide exercises in a formulated, comprehensive therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell in view of Del Fabbro with the exercising of Walker in order to instruct for exercise, including hand grip exercising, as part of a formulated, comprehensive therapy for the whole patient.
The rationale for combining in this manner is that to recommend or provide instructions for using the machine for physical therapy or treatment, including hand grip exercising, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide exercises in a formulated, comprehensive therapy for the whole patient as explained above.
Claim 17: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 13, but does not appear to explicitly disclose wherein the one or more instructions for head lifting exercises represent exercises to lift and position a head of the subject at a predetermined angle from a reference plane. Walker, though, teaches an exercise apparatus for “physical therapy, body building, strengthening, toning, and the like” (Walker at column:lines 8:16-39, quoting 38-39), including “A rotational resistance exercise apparatus [that] resists the rotation of a person's head. A person's head has an axis of rotation about which the head can turn left and right” (Walker at 14:2-28), and includes hand grip exercising capabilities (Walker at 31:51-56, 32:34-41), where the Examiner notes that head lifting is merely a different axis of rotation that can performed in the same manner based on the relative body position of the subject. Therefore, the Examiner understands and finds that to recommend or provide instructions for using the machine for physical therapy or treatment, including lifting a subject’s head, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide exercises in a formulated, comprehensive therapy for the whole patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell in view of Del Fabbro with the exercising of Walker in order to instruct for exercise, including lifting a subject’s head, as part of a formulated, comprehensive therapy for the whole patient.
The rationale for combining in this manner is that to recommend or provide instructions for using the machine for physical therapy or treatment, including lifting a subject’s head, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide exercises in a formulated, comprehensive therapy for the whole patient as explained above.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over O’Connell in view of Del Fabbro in further view of Tam et al. (U.S. Patent Application Publication No. 2016/0220175, hereinafter Tam)
Claim 30: O’Connell in view of Del Fabbro discloses the digital apparatus of claim 29, but does not appear to explicitly disclose the processor further configured to :determine whether the additional instructions are provided for the first time, and if the additional instructions are provided for the first time, provide a tutorial module. Tam, though, teaches “including tutorials, videos and quizzes to help the patient learn about the procedure, the anesthesia, the inpatient stay, outpatient process, recovery, physical therapy and/or any other educational materials the providers may want to incorporate” and that “the patient may also setup their sponsors, such as a spouse, family member and/or others who will be willing to help them stick to their physical therapy exercises both pre- and post-op” (Tam at 0060). Therefore, the Examiner understands and finds that to provide a tutorial, including for the first time an exercise is performed, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to help the patient learn about the procedure.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the exercise instructions of O’Connell in view of Del Fabbro with the tutorials of Tam in order to provide a tutorial, including for the first time an exercise is performed, so as to help the patient learn about the procedure.
The rationale for combining in this manner is that to provide a tutorial, including for the first time an exercise is performed, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to help the patient learn about the procedure as explained above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cleveland Clinic, Cachexia (Wasting Syndrome), downloaded 2 January 2025 from https://my.clevelandclinic.org/health/diseases/cachexia-wasting-syndrome, indicating cachexia is also called wasting syndrome.
Cleveland Clinic, Vagus Nerve, downloaded 2 January 2025 from https://my.clevelandclinic.org/health/body/22279-vagus-nerve, indicating that “The vagus nerve, also known as the vagal nerves, are the main nerves of your parasympathetic nervous system” (at p. 2), and “Vagus nerve stimulation (VNS) uses electrical impulses to stimulate your left vagus nerve. Healthcare providers implant a small device in your chest, under your skin. A wire runs under your skin connecting the device and nerve. The device sends mild, painless electrical signals through your left vagus nerve to your brain. These impulses calm down irregular electrical activity in your brain” (at p. 4).
Padilha. “Resistance Exercise Attenuates Skeletal Muscle Oxidative Stress, Systemic pro-Inflammatory State, and Cachexia in Walker-256 Tumor-Bearing Rats.” Applied physiology, nutrition, and metabolism. 42.9 (2017), pp. 916-923, downloaded from https://research.ebsco.com/c/kxcca7/viewer/pdf/w3pvlyow6n on 1 January 2026, indicating “Muscle wasting is the principal component of cancer cachexia” (at 917).
Kramer et al., Exercise, MAPK, and NF-κB signaling in skeletal muscle, Journal of Applied Physiology 2007 103:1, 388-395, downloaded 2 January 2026 from https://journals.physiology.org/doi/full/10.1152/japplphysiol.00085.2007, indicating “Chronic inflammation and metabolic dysregulation are prominent features of diabetes, cardiovascular disease, and cachexia” (at 388).
Schwartz (U.S. Patent No. 5,330,507) indicates that “vagal stimulation for the treatment of supraventricular arrhythmias, angina pectoris, and heart failure with an automatic, permanently implantable, medical device has been reported in the literature at least as far back as the early 1960's. The paper "Vagal Tuning" by Bilgutay et al. in the Journal of Thoracic and Cardiovascular Surgery, Vol. 56, No. 1, July 1968, pp 71-82 described the concepts of vagal stimulation in the treatment of supraventricular arrhythmias, angina pectoris, and heart failure employing an implantable vagal stimulator. Vagal stimulation was effected through the application of electrical stimulation to the vagus nerve by silastic coated, bipolar electrodes (of the type disclosed in Medtronic U.S. Pat. No. 3,421,511) surgically placed around the intact nerve or nerves” (at column 1, lines 15-29).
Terry, Jr. et al. (U.S. Patent Application Publication No. 2003/0040774, hereinafter Terry) indicates that “Kamath reported on the neurocardiac responses to vagoafferent electrostimulation in eight patients with vagal stimulation for the control of epilepsy (Pace 1992, Vol 15, 1581-1587)” (at 0011) and “The present invention, in one of its implementations, provides vagal stimulation … to limit the upper heart rate of the patient to a physiologically safe limit, such as 100-150 beats-per-minute (BPM). The stimulation is commenced whenever the BPM exceed a predetermined threshold, such as 90 BPM. The rate of cardiac vagus stimulation has an inverse effect on the heart rate. The stimulation rate may be experimentally determined and appropriately adjusted to achieve a particular heart rate for each patient during a treadmill test. For example, vagus nerve stimulation at 6 Hz may be determined to reduce the resting heart rate to 60 BPM. The physician might initiate the treadmill exercise and determine that by programming the vagus nerve stimulation rate to 4 Hz, the heart rate will be limited to about 100 BPM” (at 0012).
Boveja (U.S. Patent Application Publication No. 2005/0131467) indicates that “The method and system of the current invention utilizes an implantable pulse generator, or an external stimulator in conjunction with an implanted stimulus-receiver to provide therapy, or alleviation of symptoms for certain cardiovascular disorders, such as atrial fibrillation, congestive heart failure (CHF), inappropriate sinus tachycardia, and refractory hypertension. The method and system of this invention delivers pre-determined electrical pulses for neuromodulation of the vagus nerve(s) with an implanted pulse generator (IPG), or an external stimulator along with an implanted stimulus-receiver” (at 0004) and “Since right vagus nerve stimulation lowers the heart rate, it also lowers the exercise tolerance of the patient” (at 0024).
Libbus et al. (U.S. Patent Application Publication No. 2014/0135863, hereinafter Libbus) indicates that “This application relates in general to chronic cardiac dysfunction therapy and, in particular, to an implantable neurostimulator-implemented method for enhancing post-exercise recovery through vagus nerve stimulation” (at 0001), and “Conventional general therapeutic alteration of cardiac vagal efferent activation through electrical stimulation targets only the efferent nerves of the parasympathetic nervous system, such as described in Sabbah et al., "Vagus Nerve Stimulation in Experimental Heart Failure," Heart Fail. Rev., 16:171-178 (2011), the disclosure of which is incorporated by reference. The Sabbah paper discusses canine studies using a vagus nerve stimulation system, manufactured by BioControl Medical Ltd., Yehud, Israel, which includes an electrical pulse generator, right ventricular endocardial sensing lead, and right vagus nerve cuff stimulation lead” (at 0007).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT D GARTLAND whose telephone number is (571)270-5501. The examiner can normally be reached M-F 8:30 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685