DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the application filed on 06/06/2024.
Claims 1-22 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statement filed 06/06/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. As such, all references have been considered except for those marked through.
Claim Objections
Claim 8 discloses, “or move to the immediate treatment module. Wherein the treatment module…” Thus, disclosing a period in the middle of the claim. See MPEP 608.01(m), “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).” Appropriate correction is required.
Claim Interpretation
Examiner notes that in regards to the providing steps of independent claims 1, 8, 17, and 21, the broadest reasonable interpretation of the providing steps only indicates making the various modules available (the setup module (of claim 1), system setup module (of claim 8), monitoring module, treatment module (of claims 1, 8, and 21), immediate treatment module (of claims 1 and 8), monitoring system, diagnostic phase, treatment phase (of claims 17)) and does not actually claim executing the modules. As such, the claims do not actually perform the steps of the various modules, the monitoring system, and the diagnostic and treatment phases of claim 17. As such, the providing steps are broadly disclosed.
Further, the following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A setup module and a system setup module
A monitoring module and a monitoring system
A treatment module
An immediate treatment module
Because these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner has reviewed the as filed disclosure and determined the following:
A setup module (claim 1) and a system setup module (claim 8)
Page 9, lines 5-12 discloses “the system setup module provides for setting up the initial requirements of the system. At least one computerized device is provided, and system software is pre-loaded into the at least one computerized device. The at least one computerized device can be comprised of at least one of any suitable computerized device known in the art, which can include, e.g., a server, io personal computer, smartphone, or tablet.” Based on this and Figures 1-5, the Examiner is interpreting the immediate setup module as software that is implemented on the computing device 12. Thus, there is proper support for the setup module.
A monitoring module (claims 1, 8, and 21) and a monitoring system (claim 17)
Fig. 7A discloses a monitoring system and the monitoring module as well as a preloaded program in the monitoring system. Page 9, lines 5-12 discloses “the system setup module provides for setting up the initial requirements of the system. At least one computerized device is provided, and system software is pre-loaded into the at least one computerized device. The at least one computerized device can be comprised of at least one of any suitable computerized device known in the art, which can include, e.g., a server, io personal computer, smartphone, or tablet.” Figure 3 displays what the examiner is interpreting as software that is being enabled on the computing device to monitor incoming data and not as a device that is collecting the patient data. Wherein the computing device is shown in Fig. 2 for the system setup module and then discloses “to the monitoring module,” thus implying that the monitoring module is running on the computing device. Therefore, there is enough support for the monitoring module.
A treatment module (claims 1, 5-6, 8, 13, 21-22)
Page 9, lines 5-12 discloses “the system setup module provides for setting up the initial requirements of the system. At least one computerized device is provided, and system software is pre-loaded into the at least one computerized device. The at least one computerized device can be comprised of at least one of any suitable computerized device known in the art, which can include, e.g., a server, io personal computer, smartphone, or tablet.” Based on this and Figures 1-5, the Examiner is interpreting the treatment module as software that is implemented on the computing device 12. However, there is no disclosure of the algorithm that the treatment module utilizes to implement the various limitations disclosed in the claims. Thus, there is not proper support for the algorithm of the treatment module, as further presented in the following 112(a) and 112(b) rejections.
An immediate treatment module (claims 1, 6, 8, 13, 19, and 22)
Page 9, lines 5-12 discloses “the system setup module provides for setting up the initial requirements of the system. At least one computerized device is provided, and system software is pre-loaded into the at least one computerized device. The at least one computerized device can be comprised of at least one of any suitable computerized device known in the art, which can include, e.g., a server, io personal computer, smartphone, or tablet.” Based on this and Figures 1-5, the Examiner is interpreting the immediate treatment module as software that is implemented on the computing device 12. Further, Page 23 discloses, “If the condition is concerning enough that careful monitoring or a doctor or urgent care visit is indicated, this may be referred into the immediate treatment module 40 with is a yellow indicator, meaning that contacting a medical professional is important and should be done soon, but is not urgent. An urgent condition needing immediate treatment, such as a 911 call and immediate transport to a medical professional, can be signaled in red.” Thus, the specification discloses the proper support for the immediate treatment module as there is proper support for the hardware and for the algorithm that carries out the immediate treatment.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Original claims may lack written description when the claims define the invention in functional
language specifying a desired result but the specification does not sufficiently describe how the function
is performed or the result is achieved. For software, this can occur when the algorithm or
steps/procedure for performing the computer function are not explained at all or are not explained in
sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other
words, the algorithm or steps/procedure taken to perform the function must be described with
sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the
function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
The level of detail required to satisfy the written description requirement varies depending on
the nature and scope of the claims and on the complexity and predictability of the relevant technology.
Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v. Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078,
1083-84 (Fed. Cir. 2005). Computer-implemented inventions are often disclosed and claimed in terms of their functionality. For computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software due to the interrelationship and interdependence of computer hardware and software. The critical inquiry is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Vasudenvan Sofware, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly & Co, 598 F.3d 1336, 1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) in the context of determining possession of a claimed means of accessing disparate databases).
Claims 1, 5-8, 13, and 21-22 recite a “treatment module” and claim 17 recites “providing at least one diagnostic possibility if the continuous monitoring reveals a reading outside of the determined normal range for the at least one biological condition.”
Claim 5, 8, and Applicant’s specification page 11 disclose that the treatment module is comprised of a diagnostic and treatment phase. Wherein the diagnostic phase discloses “a step of generating a list of at least one probable diagnosis” (Claims 5, 8) and the treatment phase discloses “providing a treatment plan from the list of at least one probable diagnosis” (claim 5), “providing a treatment plan” (claim 8), “recommending at least one treatment if the at least one diagnostic possibility is provided,” (Claim 17).
Claims 1 and 21 discloses, “providing a treatment module configured to assist in carrying out basic treatment.”
Claims 6-7 and 22 discloses “treating the at least one condition within a treatment module.”
The above-mentioned limitations are not sufficiently described. At best, the applicant only alleges that they have the ability to output a diagnosis, recommend a treatment, treat a condition within a treatment module, or assist in carrying out. The broad disclosure of the result that is desired is not providing an adequate written description of the invention.
There is no disclosure of the algorithm used to determine “at least one probable diagnosis” (claim 5) or “at least one diagnostic possibility” (claim 17). The disclosure of “outside of the determined normal range” is not enough to satisfy the written description requirement as there is no disclosure of a specific range considered as “normal”. Further, the specification does not disclose how a diagnosis is determined based on this range such as a specific condition based alone on “a reading outside of the determined normal range.” At best, the Applicant claims the ability to determine that a user’s data is outside of the determined normal range but not a specific diagnosis as there is no description on the correlation between a condition and the deviation from the normal range.
Further, there is no disclosure of the algorithm used to determine the treatment based on the diagnosis as claimed in claims 5 (and it’s independent claim 1 through the treatment module) and 17. There could be a plurality of various treatments for any given diagnosis (as disclosed by the Applicant by differentiating a basic treatment versus an immediate treatment or an allopathic treatment versus a homeopathic treatment) and there is no disclosure how the system determines a treatment based on the diagnosis.
In regards to claim 21, there is no algorithm for how the treatment module assists in carrying out basic treatment and how the system determines that the patient requires a basic treatment (and not a different type of treatment).
Further, there is no disclosure of the algorithm or hardware used for “treating the at least one condition within a treatment module” of claims 6-7 and 22 as based on the specification the Examiner is interpreting the treatment module to be software that is executed on a general computerized device that outputs a treatment plan and not a device that would actually be capable of administering a treatment.
It is noted that simply stating the use of artificial intelligence does not satisfy the written description requirement as the algorithm used by the artificial intelligence is still required.
Dependent claims are rejected as dependent on a rejected base claims.
Thus, Claim 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first
paragraph, as failing to comply with the written description requirement.
Claim Rejections - 35 USC § 112(b)
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 1-16 and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “treatment module” of claims 1, 5-6, 8, 13 and 21-22 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Further, there is no disclosure of the algorithm used to determine “at least one probable diagnosis” (claim 5). The scope of the claims are indefinite as it is unclear how the system determines a diagnosis or diagnostic possibility based on being outside a normal range such as a specific condition based on “outside of the determined normal range.” As such, the specification fails to clearly link the structure, material, or acts to the function. At best, the Applicant claims the ability to determine that a user’s data is outside of the determined normal range but not a specific diagnosis as there is no description on the correlation between a condition and the deviation from the normal range.
Further, there is no disclosure of the algorithm used to determine the treatment based on the diagnosis as claimed in claim 5 (and it’s independent, claim 1, through narrowing the treatment module of claim 1). There could be a plurality of various treatments for any given diagnosis (as disclosed by the Applicant by differentiating a basic treatment (does not require use of medical facilities or a prescription per claim 21) versus an immediate treatment (contacting a medical professional, making an appointment, or calling 911 as per page 14 of the Applicant’s specification) or an allopathic treatment versus a homeopathic treatment [wherein page 9 discloses non-prescription treatment products and products … from a nutrition or health store thus indicating that there are multiple products that could be selected]) and there is no disclosure how the system determines one specific treatment is necessary based on the diagnosis. As such, these claims are indefinite.
In regards to claim 21, there is no algorithm for how the treatment module assists in carrying out basic treatment and how the system determines that the patient requires a basic treatment (and not a different type of treatment).
Further, there is no disclosure of the algorithm or hardware used for “treating the at least one condition within a treatment module” of claims 6-7 and 22 as based on the specification the Examiner is interpreting the treatment module to be software that is executed on a general computerized device that outputs a treatment plan and not a device that would actually be capable of administering a treatment.
Dependent claims are rejected as dependent on a rejected base claim.
Therefore, the claims are indefinite and does not 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 and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Additionally, claim 12 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 12 recites the limitation “at least one other iterations of the same data for the at least one other user, .” There is insufficient antecedent basis for “at least one other user” in the claim. The Examiner is interpreting the limitation to read as, “at least one other iterations of the same data for the at least one user.”
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to an abstract idea without significantly more. Claims 1-22 are directed to a system, method, or product which are one of the statutory categories of invention. (Step 1: YES).
Independent Claim 1 discloses a method of providing an artificial intelligence based home health system, comprising the steps of: providing a setup module configured to set up the initial requirements of the system, wherein the setup module is further comprised of the step of providing at least one computerized device, providing a monitoring module configured to monitor at least one condition of at least one user, providing at least one diagnostic possibility, providing a treatment module configured to assist in carrying out basic treatment, and providing an immediate treatment module configured to become alerted when the user needs immediate medical treatment.
Independent Claim 8 discloses a method of providing an artificial intelligence based home health system comprising the steps of: providing a system setup module configured to set up the system, wherein the system set up module is comprised of the steps of; providing at least one computerized device, and providing system software configured to operate the system, and loading the system software into the at least one computerized device providing a monitoring module comprised of the steps of; creating a patient profile that includes data of at least one user to be monitored, continuously monitoring the at least one user, detecting when the at least one condition falls outside a normal range as determined for the at least one user by the system, providing a treatment module and immediate treatment module, and recommending whether to; treat the user within the treatment module, or move to the immediate treatment module. herein the treatment module is further comprised of; a diagnostic phase comprising generating a list of at least one probable diagnosis, and a treatment phase comprising providing a treatment plan
Independent Claim 17 discloses a method of providing an artificial intelligence based home health system, comprising the steps of: providing at least one computerized device, providing system software to the at least one computerized device, wherein the system software is configured to operate the home health system, collecting data of at least one user and constructing at least one patient profile of the at least one user, providing a monitoring system connected to the at least one computerized device, determining a normal range of at least one biological condition of the at least one user based on data in the patient profile, continuously monitoring the at least one patient with the monitoring system to continuously determine whether the at least one biological condition stays within the determined normal range, providing a Diagnostic Phase comprised of the step of; providing at least one diagnostic possibility if the continuous monitoring reveals a reading outside of the determined normal range for the at least one biological condition, and providing a Treatment Phase comprised of the step of; recommending at least one treatment if the at least one diagnostic possibility is provided.
Independent Claim 21 discloses a method of providing an artificial intelligence based home health system, comprising the steps of: providing at least one computerized device with software to operate the system, providing a monitoring module configured to monitor at least one condition of at least one user, providing a treatment module configured to assist in carrying out basic treatment, wherein the basic treatment does not require use of medical facilities or a prescription.
The examiner is interpreting the above bolded limitations as additional elements as further discussed below. The remaining un-bolded limitations are merely directed to determining a diagnosis and treatment plan based on collected user data in claims 1, 8, and 17 and assisting in carrying out a basic treatment in claim 21. The series of steps recited above describe managing personal behavior or relationships or interactions between people and thus are grouped as certain methods of organizing human activity which is an abstract idea.
Further, the above un-bolded limitations describe a mental process because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgements, and/or opinions – in this case, the steps of monitoring at least one user (of claims 1, 8, 17, and 21), providing [generating] at least one diagnostic possibility/probable diagnosis, (claim 1, 8, and 17), assisting in carrying out basic treatment (of claims 1 and 21), and alerting when the user needs immediate medical treatment (of claim 1), providing a treatment plan (of claim 8), recommending at least one treatment (of claim 17), detecting when the at least one condition falls outside a normal range and determining a reading outside of the determined normal range for the at least one biological condition (of claims 8 and 17) is reasonably interpreted as at least evaluations that could be performed by a human mentally or using a pen and paper.
The limitations are considered together as a single abstract idea for further analysis. (Step 2A- Prong 1: YES. The claims are abstract).
This judicial exception is not integrated into a practical application. Limitations that are not indicative of integration into a practical application include: (1) Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Claim 1 discloses the following additional elements:
An artificial intelligence based home health system
A setup module
At least one computerized device
A monitoring module
A treatment module
An immediate treatment module
Claim 8 discloses the following additional elements:
An artificial intelligence based home health system
A system setup module
At least one computerized device
System software configured to operate the system
A monitoring module
A treatment module
An immediate treatment module
Claim 17 discloses the following additional elements:
An artificial intelligence based home health system
At least one computerized device
System software [provided] to the at least one computerized device configured to operate the home health system
A monitoring system
Claim 21 discloses the following additional elements:
An artificial intelligence based home health system
At least one computerized device
Software to operate the system
A monitoring module
A treatment module
In particular, the artificial intelligence based home health system, (of claims 1, 8, 17, and 21), the setup module (of claim 1), the system set up module (of claim 8), the at least one computerized module (of claims 1, 8, 17, and 21), the monitoring module, the treatment module (of claims 1, 8, and 21), immediate treatment module (of claims 1 and 8), monitoring system (claim 17), system software configured to operate the system (claim 8), system software [provided] to the at least one computerized device configured to operate the home health system (claim 17), and software to operate the system (claim 21) are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception.
The Applicant’s specification Page 9, lines 5-10 disclose “the system setup module provides for setting up the initial requirements of the system. In a preliminary step, at least one computerized device is provided, and system software is pre-loaded into the at least one computerized device. The at least one computerized device can be comprised of at least one of any suitable computerized device known in the art, which can include, e.g., a server, io personal computer, smartphone, or tablet.” Thus, the various modules and the monitoring system are software on a computerized device. As such, the modules and monitoring system are mere instructions to implement the abstract idea on any suitable computerized device known in the art.
Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Accordingly, claim(s) 1, 8, 17, and 21 are directed to an abstract idea(s) without a practical application. (Step 2A-Prong 2: NO: the additional claimed elements are not integrated into a practical application).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the artificial intelligence based home health system, (of claims 1, 8, 17, and 21), the setup module (of claim 1), the system set up module (of claim 8), the at least one computerized module (of claims 1, 8, 17, and 21), the monitoring module, the treatment module (of claims 1, 8, and 21), immediate treatment module (of claims 1 and 8), monitoring system (claim 17), system software configured to operate the system (claim 8), system software [provided] to the at least one computerized device configured to operate the home health system (claim 17), and software to operate the system (claim 21) amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more’). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Accordingly, even in combination, these additional elements do not provide significantly more. As such the independent claims 1, 8, 17, and 21 are not patent eligible. (Step 2B: NO. The claims do not provide significantly more).
Dependent claim(s) 2-7, 9-16, 18-20, and 22 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Dependent claims 2 do further disclose the additional element(s) of system software configured to perform the functions of the system and loading the system software into the at least one computerized device (claim 2), interactive audio/visual module and a monitoring station or a monitoring network (claim 14), a first or second machine learning model (claim 18), an immediate treatment module (claim 19, wherein the claim from which it depends (claim 17) does not previously disclose this module though it has been addressed above in regards to other independent claims), a parent database (claim 20), a system setup module (claim 22, wherein the claim from which it depends (claim 1) does not previously disclose this module though it has been addressed above in regards to other independent claims).
In particular, the system software configured to perform the functions of the system and loading the system software into the at least one computerized device (claim 2), interactive audio/visual module and a monitoring station or a monitoring network (claim 14), a first or second machine learning model (claim 18), an immediate treatment module (claim 19), a parent database (claim 20), a system setup module (claim 22) are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the system software configured to perform the functions of the system and loading the system software into the at least one computerized device (claim 2), interactive audio/visual module and a monitoring station or a monitoring network (claim 14), a first or second machine learning model (claim 18), an immediate treatment module (claim 19), a parent database (claim 20), a system setup module (claim 22) amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more’). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1-22 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 8-11, 13-14, 16, and 21-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Holes (US PG Pub 2025/0107716 A1).
Regarding Claim 1, Holes discloses:
A method of providing an artificial intelligence based home health system, comprising the steps of:
providing a setup module configured to set up the initial requirements of the system, wherein the setup module is further comprised of the step of providing at least one computerized device, (Para 62 discloses FIG. 1 shows a block diagram of a telehealth system according to an exemplary embodiment of the disclosure. The telehealth system comprises an all-in-one bio-monitoring device 100. The bio-monitoring device comprises sensor module units 101, a CPU processor 116, algorithms and monitoring 121, a machine learning artificial intelligence module 130, a network interface 140, a GPS module 145, data transmission client 150, a user interface 160, at least one port 170A and 170B, and at least one adapter 180A and 180B. Para 142 discloses in an additional set up of the health monitoring medical device a user may select settings for monitoring modes and/or continuous monitoring automation 8I19. In this process the user first selects the monitoring frequency setup setting on the medical device 8I20. Then the user may select the monitoring mode 8I21 which may be single use mode 8I22, multiple single Sensor mode (which may be for 1 or more sensors using continuous automation) 8I23 or continuous use mode 8I24.)
providing a monitoring module configured to monitor at least one condition of at least one user, (Para 8 discloses this model of patient medical care can be best described as a Coordinated Care model, which achieves a higher standard of patient care through constant monitoring of a patient, real-time updates, and interoperable patient communications. Monitoring can include remote patient monitoring to single use observation for a telehealth visit. Para 47 and FIG. 8e disclose a schematic diagram depicting a remote patient monitoring system capable of utilizing data, including data from provider encounters, medical device readings and interactions, medical assessments, and patient messages sent to provider for the purpose of analyzing the data through artificial intelligence and determining if there is a medical event such as an emergent health situation or a deterioration in their normal health pattern, which may require a response. Furthermore, a scoring metric for each component is applied based upon incoming data results and are applied to influence the weights of analysis by the artificial intelligence models. See Further: Para 17.)
providing at least one diagnostic possibility, (Para 15 discloses it's this plus the platform and observations and other aspects that allow for the ultimate capability to observe, diagnose, and treat from a comprehensive medical monitoring and coordinated care platform. Para 98 discloses as described in FIG. 4 and FIG. 5, both patient health information and medical device readings may be applied to an artificial intelligence algorithm to increase the diagnostic prediction of an ECG reading 6X21. Para 125 discloses once features and their descriptors are extracted, they are compared to a database of known targets 8F11. The AI/ML algorithm attempts to find the closest matching features between the current frame and the known target features. A target match score is generated and transmitted to a large medical data model (LMDM) AL/ML algorithm for score metrics analysis, which may be used to determine, directly on the device 8F6, if there is a medical concern or an emergent medical condition [at least one diagnostic probability], which may be described as Edge AI or Endpoint AI. The objective is to compare a target image match 8F7 with the associated target match score 8F8 and determine its medical relevance. The system 8F10 assesses if there's a correlation with known medical conditions from the patient's medical history, leading to potential emergency medical alerts, diagnostic indicators, or general diagnoses 8F9.)
providing a treatment module configured to assist in carrying out basic treatment, and (Para 16 discloses if such as providing health updates that can be communicated to a person in an easy-to-understand manner. For example, a patient can be notified of an urgent medical situation, and, through cognitive automation and artificial intelligence, a person can be notified automatically of the medical situation in an easy-to-understand manner, which explains to the patient what the situation means to them and what type of response is appropriate. As an example, a high AIC reading [another example of a reading outside of the determined normal range] might result in a notification to the patient that the patient should eat healthier [recommending at least one [basic] treatment wherein based on the Applicant’s specification pages 8-9, “the treatment module comprises steps and equipment to carry out basic treatment” where claim 21 discloses a basic treatment does not require a medical facility or prescription, Holes reads on the treatment module assisting in carrying out basic treatment (eat healthier, a treatment that does not require a medical facility or prescription)].)
providing an immediate treatment module configured to become alerted when the user needs immediate medical treatment. (Para 28 discloses where the present invention detects an emergency in progress, methods disclosed herein may include contacting emergency services for immediate treatment of the patient without the need for human monitoring in real-time. Para 148 discloses FIG. 9 is a schematic representation of an application of graphic user interface 9X2, monitoring 9X4 and notification of emergency to medical staff responder 9X1. The responder is connected to a network 245 that provides patient alert reporting summary 9X6, patient B&G in critical condition 9X7, and response protocol 9X8. The responder 9X9 is also connected to an enhanced 911 call service 9X10 to initiate emergency treatment of the patient, based upon multiple patient observation application graphic user interface administration panel. Para 151-153 discloses patient B has a reported low pulse oximeter reading of 85% and should be considered an emergency. The monitoring dashboard [immediate treatment module configured to become alerted…] may provide indicators that focus attention on Patient B as in need of medical attention. Another patient, patient G, has a high blood pressure and elevated heart rate with a very high temperature and should be considered of a status of a critical medical emergency… Continuing the example, the patient monitoring dashboard must alert the observing staff member that patient B and patient G have an emergent medical condition as transmitted from the medical device of each patient. Para 232 discloses In another example embodiment, the medical device may further comprise a method wherein the device conducts a health risk analysis utilizing algorithms and artificial intelligence to recognize an emergent event and automatically contact an emergency medical service and/or an enhanced 911 services.)
Regarding Claim 2, this claim recites the limitations of Claim 1 and as to those limitations is rejected for the same basis and reasons as disclosed above. Holes further discloses:
A method of providing an artificial intelligence based home health system, according to Claim 1, wherein the system setup module is further comprised of the steps of: providing system software configured to perform the functions of the system, and loading the system software into the at least one computerized device. (Para 67 discloses the networks 200 and 240 may also be connected to an all-in-one bio-monitoring video and/or audio medical device 900 comprising sensor units 901, a CPU processor 915, a network interface 920, further comprising a network transceiver 921, RAM/memory 922, storage 923, battery 924, and a user interface 925 and may have additional on-device software applications. Para 187 discloses the apparatus further comprises a module for data processing and execution of instructions. This module is configured to record the patient's biological data and execute on-device machine learned artificial intelligence, computer vision for video and image data analysis, and at least one artificial intelligence algorithm for audio data analysis. Paras 194-195 disclose the present disclosure relates to a medical device that can be worn for monitoring of a person's vital signs. In an example embodiment, the device comprises a housing, a display at least partially surrounded by the housing, and at least one component for gathering a person's data that is at least partially surrounded by the housing… a computing component implemented by one or more processors configured with instructions in a non-transitory memory, that when executed cause the one or more processors to record the patient's biological data and execute on-device machine learned artificial intelligence… See Further: Para 191)
Regarding Claim 3, this claim recites the limitations of Claim 1 and as to those limitations is rejected for the same basis and reasons as disclosed above. Holes further discloses:
A method of providing an artificial intelligence based home health system, according to Claim 1, wherein the monitoring module is further comprised of the steps of: creating a patient profile of collected data regarding the at least one user to be monitored, and (Para 23 discloses patient data is stored with the patient's profile and requires that the patient grant access to providers or caregivers for access to their information. This workflow allows for all the patient's data to be stored in one place, rather than with individual providers. Para 94 discloses Patient data may be collected from the medical device itself 4X1 through an on-device application and user interface 4X2. A user profile may be created on the device and the user may include their demographic information 4X3 and health information 4X7, which may include the user's age, date of birth, he