DETAILED ACTION
This office action is based on the claim set submitted and filed on 09/02/2025.
Claims 1, 8, and 15 have been amended.
Claims 1-20 are currently pending and have been examined.
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 .
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(s) 1-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In order to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2161.01(1). However, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed, and even original claims may fail to satisfy the written description requirement when the invention is claimed and described in functional language but the specification does not sufficiently identify how the invention achieves the claimed function, See MPEP 2161.01(1) citing in part Ariad, 598 F.3d at 1349 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries.").
Specifically, with regard to computer-implemented functional claims, the specification must provide a disclosure of the computer and the algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, including how to program the disclosed computer to perform the claimed function. MPEP 2161.01(1).
Claim 1, 8, and 15, recite “applying the another round of sleep intervention including an electrical stimulus to a brain a of the user based on the one or more treatment parameters”, for which the subject matter of the limitation 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, at the time the application was filed, had possession of the claimed invention. As best understood, it appears that there is no support for the underlined recitation in the original disclosure of the present application for this limitation for which the examiner takes the position that with respect to these limitations or features of the claims, the specification fails to provide an adequate written description of the invention in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, to an extent that would sufficiently show that applicant was in possession of an invention that could operate as claimed. The specification does not describe the underlined. The examiner has no idea how applicant actually contemplated doing the step because nothing is disclosed other than the broad disclosure of the specification providing an estimation of what another round of a treatment may cause, (see Applicant, 0053). This does not satisfy the written description part of 112(a) in the opinion of the examiner. Therefore, these limitations of the claims are considered to be new matter.
The examiner takes the position that with respect to these limitations or features of the claims, the specification fails to provide an adequate written description of the invention to an extent that would sufficiently show that applicant was in possession of an invention that could operate as claimed. Simply disclosing a vague description, without actually explaining how to perform the function(s) claimed, results in a written description problem under 112(a). The examiner has no idea how applicant actually contemplated doing these steps because nothing is disclosed other than the broad disclosure of the specification as mentioned above.
Therefore, applicant has failed to show the actual subject matter in their possession at the time of the invention in a way sufficient to reasonably convey to one skilled in the relevant art that applicant had possession of the claimed invention at the time the application was filed. Therefore, these limitations of the claims are considered to be new matter. Appropriate correction is required.
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.
Claim 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-7 are drawn to a method, Claims 8-14 are drawn to a system/device, and Claims 15-20 are drawn to an art of manufacturer, and each of which is within the four statutory categories (i.e. a machine and a process). Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for determine a sleep disorder intervention and recommended an improvement. Evaluating physiological and mental condition is an abstract idea that could have been performed by a human mind but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for steps citing a process of identifying condition and recommendation for improvement for which both the instant claims and the abstract idea are defined as metal process that can be performed using human mind with the aid of pencil and paper.
Independent claims 1, 8, 15 recite the steps of:
“receive[ing] measurement data from one or more data sources, the measurement data comprising one or more measurements of biological parameters of the user before and after a sleep intervention;
receive[ing] treatment data comprising one or more treatment parameters associated with the sleep intervention;
generate[ing], using one or more processors, a one or more quality assessment metrics based on a comparison of the one or more measurements of biological parameters before and after the sleep intervention;
train[ing] a machine learning estimation model using the one or more quality assessment metrics and the received treatment data, the machine learning estimation model being configured to generate one or more predicted results associated with one or more estimation variables associated with one or more intervention treatments, the one or more estimation variables including at least one of the one or more quality assessment metrics; and
provide[ing] one or more treatment parameters to the machine learning estimation model to provide an estimation of a result of another round of the sleep intervention
applying the another round of sleep intervention including an electrical stimulus to a brain a of the user based on the one or more treatment parameters”.
The limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations by a human mind with aid of pen and paper, thus, an abstract idea, but for the recitation of generic computer components. The claimed concept encompasses to performance of the limitations of a mental process that encompasses the user manually the ability to obtain a known data/information of a user and/or treatment parameters, analyze the information to generate quality assessment metrics, create an estimation model to predict results and run the model on sleep intervention, which are steps reciting mental process that could have been performed by a human mind with aid of pen and paper but other than the mere nominal recitation of "processors", a "machine-learning estimation model" to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which are citing a process for which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “processors, memories, machine learning model, non-transitory computer-readable storage medium” that is/are recited at a high - level of generality (i.e., as generic processors, machine learning model) to perform the steps, i.e., “train[ing]...”, “apply[ing] another round...”, that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions for generating a predicted results associated with sleep intervention treatment, as such that it amounts no more than 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, see MPEP 2106.05(f), and generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). For example, machine learning model is/are recited in the claims, under BRI, at a high level of generality and is in described in the specification in an arbitrary form without disclosing a specific training for the model or teach an algorithm using available data for allowing the model to learn patterns and relationships within the data and implement it to perform the claimed function, (see, Applicant, 0052) in addition the claim does not affirmatively recite any steps or functions that effect a particular treatment or prophylaxis for a disease or medical condition other than just applying another round of intervention, then it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “effect a particular treatment or prophylaxis”, see MPEP 2106.04(d)(2).
As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, (see, Applicant 0052) that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f) and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims are not patent eligible.
Dependent Claims 2-7, 9-14, and 16-20 include all of the limitations of claim(s) 1, 8, and 15, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2-5, 9-12, and 16-19 , the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible.
As for claims 6-7, 13-14, and 20, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “user interface, display device” that implement the identified abstract idea. These hardware components are recited at a high level of generality (i.e., general purpose computers/components implementing generic computer functions; applicant's specification makes no mention of any specific hardware) such that it amounts no more than mere instructions to apply the exception using generic computer components. These elements effectively amount to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. the additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions, (See, MPEP §2016.05(d)). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Response to Amendment
Applicant's arguments filed 09/02/2025 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 112(a) rejection on page 7-8.
On page 7-8 of the remarks, the Applicant argues “Applicant submits that there is support for "applying the another round of sleep intervention including an electrical stimulus to a brain a of the user based on the one or more treatment parameters”, however as explained by the Examiner, no where in the specification describing the argued feature. As discussed above and in the prior argument, specification [0035] describes treatment data includes stimulation parameters to apply the stimuli to the user, however such description doe not satisfy the feature “applying the another round of sleep intervention” as claimed. Applicant further articulated the argument based on the description recited in the specification ([0023], [0021], [0024], [0024], [0020], [0020], [0035]) [0029], [0035]), (Note: paragraphs entered by the Applicant in the remarks do not match description), where Examiner finds that the mentioned sections are describing an over view for a system configured for providing electrical stimuli to brain tissue via electrodes and based on parameters/treatment data representing sleep intervention that includes simulation parameters used to apply simulation to a user but does not describe "applying the another round of sleep intervention including an electrical stimulus to a brain a of the user based on the one or more treatment parameters" as claimed.
Furthermore, Applicant in the remarks argues “Applicant respectfully submit that the Examiner incorrectly stated that Figure 1 only describes...”, however Examiner finds no response/remarks by the Examiner associated with Fig. 1 in the 112(s) response to argument section. There is no description disclosed in the specification for the step of reprocessing and applying another round of sleep intervention but estimating what another round of treatment may cause as described in the above rejection. Therefore, Examiner remains the 112(a) rejection.
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 8-11.
On page 9 of the remarks, the Applicant argues “Applicant submits that:
Independent claims 1, 8, and 15 explicitly require "applying the another round of sleep intervention including an electrical stimulus to a brain of the user based on the one or more treatment parameters." This limitation cannot be performed by the human mind, contrary to the Examiner's assertion Physical application of electrical stimulation to brain tissue through electrodes requires: • Specialized medical hardware (electrodes, stimulation circuitry) • Precise electrical parameter control (voltage, current, frequency, pulse width) . Physical inte1face with brain tissue • Real-time physiological monitoring and control”, Examiner disagree. As described in the response to argument mailed 07/31/2025, the claims are given their broadest reasonable interpretation for the purpose of determining whether they encompass a judicial exception. In the current application, the claim(s) limitations, under BRI, recite steps for obtaining/collecting a user biological data and sleep data, determining sleep quality, and train a model to estimate intervention parameters and apply the intervention, which are steps other than “training” and “applying”, that can be performed using human mind and thus are directed to an abstract idea that fall within the Mental Process grouping reciting a steps for which are similar to the steps of observing, evaluating, judgment, and opinion that are citing a process for which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III), which both the instant claims and the abstract idea are defined as Mental Process.
Moreover, while the Applicant argues that the limitation cannot be performed by the human mind because it requires “• Specialized medical hardware (electrodes, stimulation circuitry) • Precise electrical parameter control (voltage, current, frequency, pulse width) . Physical inte1face with brain tissue • Real-time physiological monitoring and control”, Examiner finds that Applicant arguing features, other than electrode” that are recited in the instant claim(s). Even the electrodes are recited at a high level of generality and as a tool to implement the judicial exception. There is no actual physical application of electrical stimulation to a user's brain through electrodes is described as alleged by the Applicant, the claim does not affirmatively recite any steps or functions that effect a particular treatment or prophylaxis for a disease or medical condition other than just applying another round of intervention as such is an additional element to the abstract idea and no more than adding the words "apply it" through leveraging computing technology in a well understood manner. As such, even when considering the claims additional elements, the claims as a whole, individually and in combination, provide no integration of the abstract ideas into a practical application that no meaningful limits on practicing the abstract idea are introduced, see MPEP 2106. The claims as a whole are therefore directed to an abstract idea.
On page 9 of the remarks, the Applicant argues “The Examiner incorrectly stated that Figure l only describes "communication between the user brain and to monitor and measure neural activity". However, the specification clearly describes both monitoring and stimulation capabilities:...”, Examiner respectfully disagree. Examiner assert that there is no actual physical application of electrical stimulation to a user's brain through electrodes is described as alleged by the Applicant with reference to Fig. 1 but rather Fig. 1 is describing a high level diagram and visual representation of the system's 100 overall components, showing major components, their interactions, and data flow process (communication) between the user brain and to monitor and measure brain activity as described in specification [0019-0020] to monitor and measure activity.
On page 10 of the remarks, the Applicant argues “Even if the data analysis portions were considered abstract, the electrical brain stimulation integrates any judicial exception into a practical application by:... 1. Effecting Particular :Medical Treatment... 2. Specific Technological Implementation... 3. Improvement to Medical Technology...”, Examiner respectfully disagree. First, Examiner asserts that the claims nor the specification describes any effect to a treatment other than the limitation for “applying the another round of sleep intervention...” that amounts to no more than mere instructions to implement “apply” the exception using a generic computer component and no more than adding the words "apply it" (or an equivalent) with the judicial exception and merely an intended use of the claimed invention or a field of use limitation that cannot integrate a judicial exception under the “effect a particular treatment or prophylaxis”, see MPEP 2106.04(d)(2).
Second, Examiner asserts that no claims reciting a specific technological implementation other than reciting a system comprising an interface, between a processing device, controller, and a human user via electrodes recited at a high level of generality and tool to perform the abstract idea. Third, as mentioned above, the claims under BRI recites an abstract idea for sleep intervention parameter while citing addition element described at high level and as tool(s) to perform the abstract idea as such the thrust of Applicant's invention is to improve the abstract idea for sleep intervention quality assessment through leveraging computing technology, e.g., processor, controller, in an understood manner. The fact that the judicial exception, identified in the rejection above, relies upon collecting user data, analyzing the data for parameters, does not impart an improvement to any existing computer, or any other technology or technical field. At best, this gathering of data to be used by substance injector device may improve the abstract idea. However, improving upon an abstract idea does not make the abstract idea any less abstract.
On page 10-11 of the remarks, the Applicant argues “Even under Step 2B analysis, the electrical brain stimulation provides significantly more than any abstract idea: 1. Not Routine or Conventional... 2. Technological Solution to Technological Problem... 3. Specific Hardware Requirements”, Examiner respectfully disagree. As mentioned above, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because the claim does not affirmatively recite any steps or functions that effect a particular treatment or prophylaxis for a disease or medical condition other than just assessing an intervention through leveraging computing technology in a well understood manner. The claims at issue do not require any nonconventional computer, network, or other components, or even a non-conventional and non-generic arrangement of known, conventional pieces but merely call for performance of the claimed functions on a set of generic computer components. Moreover, the claim(s) additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself as such the elements of the instant process, when taken alone, each execute in a manner conventionally expected of these elements. The elements of the instant underlying process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone. Hence, these additional elements do not add anything significantly more than an abstract idea.
Therefore, the Examiner has addressed the Applicant argument(s) and found this argument is not found to be persuasive. Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687