DETAILED ACTION
This office action is based on the claim set filed on 07/06/2026.
Claims 1 and 26-27 have been amended.
Claims 1-14 and 17-30 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 § 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 1-14 and 17-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-14 and 17-30 are drawn to a method, which are within the four statutory categories (i.e., a machine and a process). Claims 1-14 and 17-30 are further directed to an abstract idea on the grounds set out in detail below.
Under step 2A, prong 1, The claims of the current invention represent an abstract idea of a series of steps that recite a process evaluating a medical treatment. This abstract idea could have been performed using human mind with the aid of pencil and paper citing a process directed to providing questions and gathering responses, score the responses before and after treatment, and provide the score to the user for which both the instant claims and the abstract idea are defined as Mental Process.
Independent claims 1, 26, and 27 recite the steps of:
“receiving, by a processor, a treatment code for a patient for a treatment to be performed on the patient;
querying, by the processor, a third-party medical literature database for a medical literature article associated with the treatment code;
receiving, by the processor, a plurality of medical literature articles responsively to the query of the medical literature database;
analyzing, by the processor, the plurality of medical literature articles to identify which medical literature articles of the plurality reference an outcome measurement device;
building, modifying, or updating, by the processor, a data structure that associates the outcome measurement device referenced by each identified medical literature article with the treatment code
querying, by the processor, an outcome measurement device database to obtain the outcome measurement device referenced by each identified medical literature article;
receiving, by the processor, one or more outcome measurement devices responsively to the query of the outcome measurement device database;
generating, by the processor a medical questionnaire using the one or more outcome measurement device
facilitating, by the processor, a pre-treatment provision of the medical questionnaire to the patient before the patient is treated for a medical condition with the treatment, the medical questionnaire being associated with one or more scoring metrics stored in a scoring-metrics database and indexed to a medical symptom questionnaire;
receiving, by the processor, a pre-treatment set of responses to the medical questionnaire from the patient before the treatment is performed;
accessing, by the processor, the scoring-metrics database to retrieve the one or more scoring metrics indexed to the medical questionnaire;
evaluating, by the processor, the pre-treatment set of responses using the retrieved one or more scoring metrics;
determining, by the processor, a pre-treatment score for the medical condition based on the evaluation of the pre-treatment set of responses;
facilitating, by the processor, a post-treatment provision of the medical questionnaire to the patient following performance of the treatment;
receiving, by the processor, a post-treatment set of responses to the medical questionnaire from the patient following performance of the treatment;
accessing, by the processor, the scoring-metrics database to retrieve the one or more scoring metrics indexed to the medical questionnaire;
evaluating, by the processor, the post-treatment set of responses using the retrieved one or more scoring metrics;
determining, by the processor, a post-treatment score for the medical condition based on the evaluation of the post-treatment set of responses;
facilitating, by the processor, provision of the post-treatment score to the patient, via a display of a personal electronic device of the patient;
generating, by the processor, a notification for a healthcare provider responsively to a determination that the post-treatment score is below a minimum threshold; and
facilitating, by the processor, provision of the notification to the healthcare provider, via a display of an electronic device of the healthcare provider, wherein the notification includes contact information for the patient.”
Claim 27 recites similar limitations in Claim 1 and including the step of:
“creating, by the processor, a medical-condition-specific registry of information by indexing at least one of the received pre-treatment set of responses, the determined pre-treatment scores, the received post-treatment set of responses, and the determined post-treatment score of responses received from the plurality of patients to the medical condition”
These limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations by a human interaction(s) that constitute certain methods of organizing human activity (i.e., querying a medical literature database) and mental process. This abstract idea could have been performed by a human actor but for the fact that the claims recite a general-purpose computer implemented process to perform identified abstract idea. For example, the limitations encompass a user to manually perform the steps citing a process directed to selecting an evaluation instrument and measurement outcome for a clinical procedure and providing one or more user medical questionnaire for before and after medical treatment or intervention, receiving the user response to the questionnaires, scoring the responses, and generating a score to the user and notify provider. These limitations are examples of steps for providing and obtaining questionnaire(s) responses to determine outcomes based on scoring, which are steps that could be performed mentally and, therefore are Mental Processes. This abstract idea could have been performed by a human mind citing a process for collecting, analyzing, evaluating, and provide a score, that are steps of observing, evaluating, judgment and opinion which is/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). In addition, the step of facilitating a notification to provider via a device is an example of a claim reciting managing personal behavior that fall under the abstract grouping for Certain Methods of Organizing Human Activity. 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 additional element such as “database, processor, electronic device” that iteratively takes input data and analyzes said data to provide an output to performing generic computer functions (e.g., displaying scoring on electronic device) 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 a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). Accordingly, looking at the claims as a whole, individually and in combination, these additional elements provide no integration of the abstract ideas into a practical application because they appear to merely automate a manual process, such that no meaningful limits on practicing the abstract idea are introduced and the computing elements are merely utilized as tools to perform the abstract ideas. The claim as a whole is therefore 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, 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). 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 2-14, 17-25, and 28-30 include all of the limitations of claim(s) 1, 26, and 27, and therefore likewise incorporate the above-described abstract idea. While the depending, claims add additional limitations as the following:
As for claims 9 and 23-24, 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 a performing the steps using a human mind with the aid of pen and paper, which is a mental process, 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 2-8, 10-14, 17-22, 25, and 28-30, 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 a performing the steps using 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. This judicial exception is not integrated into a practical application. In particular, the claim(s) recite additional elements such as “processor, database, electronic medical records, personal electronic device” recited in the claim(s) at a high level and is directed to an already developed/trained model(s). The additional element(s) have been interpreted to be computing components with a general - purpose processor which is disclosed at a high - level of generality and includes known hardware (or software) components, such that it amounts to no more than mere instructions to “apply” the exception (e.g. storing”) using a generic computer component, see MPEP 2106.05(f), and uses the computer as a tool to perform the abstract idea, see MPEP 2106.05(h). Thus, the judicial exceptions recited in claims is/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. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues the substance:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 14-20.
On page 15 of the remarks, the Applicant argues “Applicant submits that the claims as amended, taken as a whole, cannot practically be performed in the human mind ... These operations are inherently technological and require computer implementation to interact with external database systems and maintain evolving data structures in a complex manner beyond the capabilities of the human mind”, Examiner respectfully disagree. Examiner asserts that the claims are given their broadest reasonable interpretation for the purpose of determining whether they encompass a judicial exception. As discussed in the above rejection, the claim(s) under BRI, recite steps such as querying literature databases and build, modifying, or updating data structure and analyzing the data to determine a treatment score that have been identified as abstract. The claim(s) recite additional elements recited at a high level of generality and as a tool to perform the abstract idea that amount no more than adding the words "apply it" (or an equivalent) with the judicial exception, e.g., “providing a notification to a user device display”. Stripping the claim of any generic computing element performing the abstract idea, other than the operating step, set forth the abstract idea. Clearly, and in light of the specifications, the claims are directed to analyzing clinical data to determine treatment wellness score as such the steps can be performed by a human as mental process along with an activity of a single person or multiple people and a computer reciting steps for following a set of instructions and thus, may fall within the Mental process along with certain methods of organizing human activity grouping, therefore an abstract idea. The claim(s), as a whole, recites an abstract idea for evaluating a treatment and nowhere the claims nor the specification recite a technical solution improving the functioning of a computer or improves another technology or technical field rather the claimed invention is describing a solution addressing an administrative activity for evaluating and scoring treatment.
On page 15-16 of the remarks, the Applicant argues “even assuming arguendo that certain individual steps of the claims could be characterized as abstract, to which Applicant does not concede, Applicant submits that the claims as amended integrate any such judicial exception into a practical application... Similarly, the claims as amended here recite a specific combination of elements... This combination of elements, like Example 42, recites a specific improvement over prior art systems for medical treatment outcome monitoring - not merely a generic application of a computer to an abstract idea”, Examiner respectfully disagree. The amended claim(s), given their broadest reasonable interpretation, is/are reciting a process for querying literature databases and build, modifying, or updating data structure and analyzing the data to determine a treatment score are reciting steps identified as abstract steps. The Applicant argued that the claim 1 recites a similar concept to Example 42 and the claim steps are integrated into a practical application as reciting a specific improvement over prior art systems for medical treatment outcome monitoring, Examiner respectfully disagree. Example 42 provides a specific interaction between network interfaces to update patient information by receiving data from different sources in different formats (non-standardized) and converting the data into a standardized format and notify in real-time the user(s) when the information is updated and provide immediate access. Example 42 claim 1 was considered to integrate this into a practical application because it allowed remote users to share the information in real time and in a standardized format. In contrast, the invention claim recites applying a processing tool for querying literature databases, build, modifying, or updating data structure, analyzing the collected data to determine a treatment score and display it. Therefore, it is respectfully submitted that the claimed invention is not analogous to that of Example 42.
On page 16-17 of the remarks, the Applicant argues “The contrast between eligible Claim 1 and ineligible Claim 2 of Example 42 further supports the eligibility of the claims as amended here ... By contrast, the claims as amended here, like eligible Claim 1 of Example 42, go well beyond merely storing and updating information. ... These specific technical steps, like the format conversion, standardized storage, and automatic message generation of eligible Claim 1 in Example 42, recite a specific improvement over prior art systems rather than a generic application of a computer to an abstract idea”, Examiner respectfully disagree. As mentioned above, the invention claims and as a mended recites applying a processing tool for querying literature databases, build, modifying, or updating data structure and using responses to determine a score for a treatment to be displayed. A claim, claim 1, that query database, build or modify or update a data structure, analyzing data, and display updated information was not considered eligible because this did not integrate the abstract idea into a practical application which is similar to Example 42 Claim 2 where a claim that stored medical records, provided access to those records for updating, and then stored updated information was not considered eligible because this did not integrate the abstract idea into a practical application. Moreover, nothing in claim 1 that recites format conversion, standardized storage and automatic message generation in real-time as in Clim1 in Example 42.
On page 17 of the remarks, the Applicant argues “Applicant further submits that the claims as amended constitute an "other meaningful limitation" that integrates any judicial exception into a practical application, as discussed in MPEP § 2106.05(e). In Example 46 (Livestock Management), ... Similarly, the claims as amended here use the scored patient responses to automatically generate notifications with patient contact information for healthcare providers when post-treatment scores fall below a minimum threshold”, Examiner respectfully disagree. While Example 46 Claim 1 recites a judicial exception, claim 2 recites the same judicial exception as claim 1, but is eligible because it recites other meaningful limitations, which, when evaluated in combination, integrate the exceptions into a practical application Example 46, claim 2 broadest reasonable interpretation is automatically sends a control signal to the feed dispenser to dispense a therapeutically effective amount of ... which adds a meaningful limitation in that it can employ the information provided by the judicial exception to operate the feed dispenser that goes beyond merely automating the abstract idea. In contrast, the argued feature for automatically generating a notification where the generating of a notification as recited in the claim, under BRI, is a mere notification that is considered an abstract step and a mere automation of manual processes, such as using a generic computer to process an application step may not be sufficient to show an improvement in computer-functionality, see MPEP 2106.05(a).
On page 18 of the remarks, the Applicant argues “like eligible Claim 3 of Example 47, the claims as amended take specific corrective action based on the analysis results - automatically generating a notification containing patient contact information for a healthcare provider ... the provider to take immediate remedial action to address a patient's potential health problems”, Examiner respectfully disagree. Example 47 claim 1 and 3 were found eligible because claim 1 does not recite a judicial exception and claim 3 as a whole integrates the judicial exception into a practical application by improving network security. More specifically, Example 47, claim 3 Examiner find that the improvement of Example 47 claim 3 is addressing a technical field that reflect an improvement in the technical field of network intrusion detection, however, providing a notification to a provider to address a problem is not an improvement in a technical field or a system. The claim(s) of the invention recites a process of determining a treatment score and notify a provider that may be an automated or a manual process which is different than what Example 47, claim 3 is performing.
On page 19 of the remarks, the Applicant argues “Applicant also submits that the claims as amended represent an improvement in medical treatment outcome monitoring technology... This integrated technical approach, reflected in the claim limitations, provides a specific improvement to medical treatment outcome monitoring systems”, Examiner respectfully disagree. As described in the above rejection and in the final office action 12/30/2025, and non-final 04/06/2026, the amended claim(s), under BRI, is/are reciting a process for facilitating treatment questionnaire score and evaluate the treatment based on responses received. The claims limitations are directed towards analyzing treatment according to the patient responses for scoring the treatment and present the outcome, which are still reciting an abstract idea which recite a mental process when they contain limitations that can practically be performed in the human mind with the aid of pen and paper, including for example, observations, evaluations, judgments, and opinions, see MPEP § 2106.04(a)(2)(III) and Electric Power Group v. Alstom., S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
Furthermore, the claim recites additional items “processor, device”, that are recited at high level of generality and as a tool to perform the identified abstract idea. 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.
On page 19 of the remarks, the Applicant argues “Assuming further arguendo that the claims as amended are directed to an abstract idea under Step 2A, to which Applicant does not concede, Applicant submits that the ordered combination of elements recited in the claims as amended provides an inventive concept under Step 2B”, Examiner respectfully disagree. As described above and in the final rejection 12/30/2025, and non-final rejection 04/06/2026, the claim(s), under BRI, recite steps for evaluating a treatment based on a patient feedback and provide a notification to a provider which encompass a judicial exception to define the identified abstract idea in addition the claim(s) recite additional elements that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, e.g., “communicating a notification to a user device display”. The claim(s), as a whole, recites an abstract idea for evaluating a treatment and nowhere the claims nor the specification recite a technical solution improving the functioning of a computer or improves another technology or technical field rather the claimed invention is describing a solution addressing an administrative activity for evaluating and scoring treatment.
In addition, the Applicant remarks do not indicate an improvement to a computer system nor a addressing a technical issue rather describing a standard behavior of any computing system according to data processing and will not cause the claim to be "directed to" something other than an abstract idea. As mentioned above, the Applicant's invention is to improve the abstract idea of process to evaluate medical treatment, through leveraging computing technology, e.g., processor, in a well understood manner. However, improving upon an abstract idea does not make the abstract idea any less abstract. Furthermore, Examiner has pointed to the computing functionality leveraged as well-understood, routine and conventional computing functionality, both individually and in combination, See MPEP 2106.05(d). 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.
On page 20 of the remarks, the Applicant argues “Applicant further submits that the Examiner's characterization of the claims as performable "using human mind with the aid of pencil and paper" is incorrect in view of the claims as amended. Building, modifying, or updating a data structure that dynamically associates outcome measurement devices with treatment codes based on automated analysis of medical literature is not an activity that can be performed with pencil and paper. Nor can a human mind query a third-party medical literature database or automatically generate notifications with patient contact information for delivery to a healthcare provider's electronic device. Additionally, the Examiner has alleged that the step of facilitating a notification to a provider via a device is "an example of a claim reciting managing personal behavior"”, Examiner respectfully disagree to the Applicant argument. As described in the above rejection and in light of the identified abstract steps, building, modifying, or updating a data structure have been identified as steps that can be performed by a human with aid of pencil and paper. In addition, query a database is an example of a step reciting judicial exception for managing personal behavior. Moreover, as discussed above, mere automation of manual processes “i.e., automatic generation of a notification”, such as using a generic computer to process an application step may not be sufficient to show an improvement in computer-functionality, see MPEP 2106.05(a). For example, querying data, analysis, generating questions and making a decision, are steps that can be performed by a human as such are identified as part of the abstract idea and provide an outcome do not indicate an improvement to a system, technological or technical field.
Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments and remarks and to comply with the 2019 Revised Patent Subject Matter Eligibility Guidance in the above Office Action.
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