DETAILED ACTION
Status of Claims
This communication is in response to the amendment filed 01/30/2026.
Claims 1-6, 8-13, 16-22 and 32-33 have been amended.
Claims 14-15 have been cancelled.
Claims 34-35 have been newly added.
Claims 1-13 and 16-35 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.
Claims 1-13 and 16-35 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-10, 21-35 are directed to non-transitory computer readable medium (i.e., a manufacture), claims 11-13 are directed to a method (i.e., a process), and claims 16-20 are directed to a system (i.e., a machine). Accordingly, claims 1-13 and 16-35 are all within at least one of the four statutory categories.
Step 2A - Prong One:
An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Representative independent claim 1 includes limitations that recite an abstract idea. Note that independent claim 1 is the computer readable medium claim, while claim 11 covers a method claim and claim 16 covers the matching system claim.
Specifically, independent claim 1 recites:
One or more non-transitory media having computer-readable instructions that, when executed by one or more hardware processors, cause the one or more hardware processors to facilitate a plurality of operations, the of operations comprising:
receiving a plurality of protocols for a plurality of clinical conditions from one or more protocol sources;
accessing, from one or more electronic health record (EHR) sources, EHR data that is specific to breathing disorder of a particular patient;
based on the EHR data being associated with the breathing disorder: receiving, from one or more current condition collectors associated with one or more external sources that are disparate from a centralized manager, current environmental conditions information associated with breathing, the current environmental conditions information including information indicating a current (a) air quality condition, (b) hazard condition, or (c) disaster event, for a population to which the particular patient corresponds;
integrating, by the centralized manager, communications connections with the one or more protocol sources, the one or more EHR sources, and the one or more external sources;
based on applying the plurality of protocols to the EHR data and applying the current environmental conditions information associated with breathing to the EHR data, identifying:
a first protocol, of the plurality of protocols, that conflicts with at least a portion of the EHR data when: an identified first numerical quantity indicates a number of criteria, within the EHR data, that are inconsistent with the first protocol; and
a second protocol, of the plurality of protocols, that is consistent with the EHR data specific to the breathing disorder;
based on applying the plurality of protocol to the HER data: generating a set of recommendations, for an action to take regarding the particular patient and the breathing disorder consistent with the second protocol and the current environmental conditions information and refraining from generating any recommendations that are consistent with the first protocol and not consistent with the second protocol;
training a machine learning model using data associated with one or both of: (i) instances of prior recommendations generated via at least a portion of the operations and i} instances of prior selections of the prior recommendations made by one or more users presented with the prior recommendations;
inputting to the machine learning model information associated with the set of recommendations;
generating a subset of the recommendations (i) utilizing the machine learning model and (ii) in response to inputting the information to the machine learning model;
communicating the subset of the second set of recommendations via a communication device to an asthma health care provider, wherein in response to the communicating via the communication device one or more courses of a particular treatment including a therapeutic dose of an asthma drug for the particular patient, determined based on the subset of the recommendations, are administered by the asthma health care provider to the particular patient to treat the breathing disorder; and
updating the machine learning model based on based on the subset of the recommendations communicated via the communication device and based further on an input received via the communication device in response to the communicating of the subset of the recommendations.
The Examiner submits that the foregoing underlined limitations constitute: (a) “certain
methods of organizing human activity” because integrating protocols of clinical conditions from protocol sources, Electronic Healthcare Record (EHR) sources, applying environmental conditions (a) air quality, (b) hazard condition, or (c) disaster event) associated with breathing, generating a set of recommendations, administering a therapeutic dose of an asthma drug and communicating a particular treatment for a particular patient being treated for a disease or medical condition to a breathing disorder are ways of utilizing health guidelines, communicating updated recommendations, accessing public health resources and providing healthcare services to a population of people, which are managing human behavior/interactions between people. Furthermore, the foregoing underlined limitations constitute (b) “a mental process” because identifying conflict in treatment protocols among a plurality of treatment protocols for consistency is an observation/evaluation/analysis that can be performed in the human mind or with a pen and paper.
Accordingly, the claim describes at least one abstract idea.
In relation to claims 9-10, 12-13 and 18, these claims merely recite specific kinds of data, such as: claim 9 - at least one of the recommendations is specific to the particular patient, claims 10 and 18 - at least one of the recommendations is specific to a patient population to which the particular patient corresponds, claim 12 – receiving additional data from one or more external sources associated with one or more of environmental information or demographical information, wherein the one or more courses of the particular treatment comprise administration of a medication to the particular patient to treat the breathing disorder, claim 13 – at least one of the recommendations is specific to one or more of the particular patient or a patient population to which the particular patient corresponds, wherein the one or more courses of the particular treatment comprise administration of an breathing disorder medication to the particular patient to treat asthma.
In relation to claims 2-3, 5-7, 14-15, 17 and 19-35, these claims merely recite determining steps such as: claim 2 – providing the first set of one or more recommendations to a health care provider, claims 3 and 15 – providing the first set of one or more recommendations to the particular patient associated with the EHR data, claims 5 and 14 – verifying at least one of the recommendations by identifying a number of criteria within the EHR data that are consistent with the second protocol, and determining that the number is greater than a predetermined threshold, claim 6 – providing at least one of the recommendations along with a ranked list of alternate recommendations, claim 7 – after identifying the first protocol as inconsistent with the criteria within the EHR data, determining to include the first protocol in a ranked list of alternate recommendations, claim 17 - to provide at least one of the recommendations to the health care provider and the particular patient associated with the EHR data, claim 19 - to receive additional data from one or more external sources associated with one or more of environmental information or demographical information, claim 20 – to provide at least one of the recommendations along with a ranked list of alternate recommendations, claim 21 – the first numerical quantity is identified based on applying the plurality of protocols and the current environmental conditions information to the EHR data, claim 22 – verifying at least one of the recommendations by comparing the first numerical quantity to a predetermined threshold number, claim 23 – the first protocol is identified as conflicting with at least a portion of the EHR data based on the first numerical quantity, claim 24 - applying the plurality of protocols and the current environmental conditions information to the EHR data, identifying a second numerical quantity that indicates a number of the criteria within the EHR data that are inconsistent with at least another protocol, claim 25 - comparing the first numerical quantity to the second numerical quantity and determining based on the comparing that the first protocol is not a preferred protocol, claim 26 - the second numerical quantity is less than the first numerical quantity, claim 27 - based on applying the plurality of protocols to the EHR data and the current environmental conditions information, determining: a second numerical quantity of the criteria within the EHR data that are consistent with at least the second protocol; and a third numerical quantity of the criteria within the EHR data that are consistent with at least a third protocol, claim 28 - comparing the second numerical quantity to the third numerical quantity and determining based on the comparing that the second protocol is a preferred protocol, claim 29 - the second numerical quantity is greater than the third numerical quantity, claim 30 - the first protocol indicates an adopted standard of care for at least one disease state, claim 31 - the second protocol indicates another adopted standard of care for a specific disease state, claim 32 - training a machine learning model based on information associated with one or more of: (i) additional instances including one or more prior recommendations generated via at least a portion of the operations and (ii) additional instances of prior selections of the prior recommendations made by one or more users presented with the prior recommendations, claim 33 - training a machine learning model based at least in part on a machine learning process selected from a group comprising supervised machine learning and unsupervised machine learning, claim 34 - in response to the communicating, receiving from the asthma health care provider via the communication device a selection of a particular recommendation from the subset of the recommendations and claim 35 - verifying a particular recommendation of the subset of the recommendations, wherein verifying the particular recommendation includes:(a) identifying a number of the criteria within the EHR data that are consistent with the second protocol; and(b) determining that the number is greater than a predetermined threshold; and in response to verifying the particular recommendation, providing the particular recommendation to the asthma health care provider and to the patient associated with the EHR data.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 11 and 16, as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the human mind but for the recitation of generic computer components. That is, other than reciting a system that includes one or more non-transitory computer-readable media, one or more hardware processors, a computer device, a communication device, communication connections and a centralized manager to perform the limitations, nothing in the claim elements precludes the steps from practically being performed by humans in the human mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation within a health care environment in the human mind but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” and “Mental Process” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the system that includes one or more non-transitory computer-readable media, one or more hardware processors, computer device, communication device, communication connections and centralized manager are recited at high levels of generality (i.e., as generic computer components performing generic computer functions of receiving data/inputs, determining and providing data) such that it amounts no more than mere instructions to apply the exception using the generic computer components.
Regarding the additional limitation “receiving a plurality of protocols for a plurality of clinical conditions from one or more protocol sources” and “receiving, from one or more electronic health record (EHR) sources, EHR data that is specific to a disease or condition, of a particular patient, associated with a breathing disorder” the Examiner submits that this additional limitation merely adds insignificant pre-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea (see MPEP § 2106.05(g)).
For claim 4 (similar to claim 1), regarding the additional limitation “the plurality of protocols and the EHR data are received at a cloud-based location” the Examiner submits that this additional limitation amounts to merely using a computer, with a video camera, to gather information to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Regarding claims 32-33, the additional limitations “training machine learning model” and “a machine learning model” the Examiner submits that this additional limitation amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvements in the functioning of a computer or an improvement to another technology or technical field, apply or us the above-noted implement/use to above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP §2106.05). Their collective functions merely provide conventional computer implementation.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer component provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, in representative independent claim 1, regarding the additional limitations of the system that includes one or more non-transitory computer-readable media, one or more hardware processors, computer device, communication device, communication connections and centralized manager, the Examiner submits that these limitations amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, representative independent claim 1 and analogous independent claims 11 and 16 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The dependent claims no not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reason discussed above with respect to determining that the dependent claims do not integrate the at least abstract idea into a practical application.
Therefore, claims 1-33 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 112
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.
Claims 1-13 and 16-35 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.
Claim 1, similar method claim 11 and system claim 16 reciting:
“refraining from generating any recommendations that are consistent with the first protocol and not consistent with the second protocol”
“training a machine learning model using data associated with one or both of: (i) instances of prior recommendations generated via at least a portion of the operations and i} instances of prior selections of the prior recommendations made by one or more users presented with the prior recommendations”
“inputting to the machine learning model information associated with the set of recommendations”
“generating a subset of the recommendations (i) utilizing the machine learning model and (ii) in response to inputting the information to the machine learning model”…………
“updating the machine learning model based on based on the subset of the recommendations communicated via the communication device and based further on an input received via the communication device in response to the communicating of the subset of the recommendations,”
but does not specifically disclose how the machine learning is done so that a person of ordinary skill in the art could recognize that the applicant had possession of the claimed invention and actually invented how the machine learning model is applied in instances of prior selections of the prior recommendations made by users, associated with sets of recommendations, generating a subset of the recommendations and refraining from generating any recommendations. Applicant’s specification only makes broad and general statements of the machine learning. The specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art and show that the inventor actually invented the claimed invention. The specification does not reasonably describe an actual machine learning model or process in a manner understandable to a person of ordinary skill in the art and show that the inventor had possession of the claimed invention. For example, the specification in paragraph 34, talks about if a user continues to select recommendations that are not initially recommended by the system 100, machine learning capabilities can be utilized to refine the recommendations, but no actual training or learning is specified with a machine learning model.
Claims 2-10, 12-13 and 17-35 incorporate the deficiencies of claims 1, 11 and 16 through dependency, and are therefore also rejected.
Response to Arguments
Applicant alleges that amended claims do not teach training a machine learning model using prior recommendations generated and selected, Free of the Prior Art, see pgs. 16-17 and 22 of Remarks – Examiner disagrees.
Beside not explaining how the invention is applied in a meaningful way and merely indicating that the claims are improvements in a technical field (IIATF), the Applicant has disregarded the Subject Matter Eligibility under 35 U.S.C. 101 analysis for identifying a judicial exception, abstract idea and should not be mistaken for a novel and nonobvious rejections under 35 U.S.C. 102 and 103. Furthermore, the "method for generating a recommendation to conduct ... testing on a human patient based on a likelihood of receiving an actionable diagnosis, the method comprising: receiving electronic health record (EHR) data ... [;] computing using a ... neural network ... a positive diagnostic indicator; generating a recommendation for administration of a [test] ...; and providing the recommendation over a user interface associated with a remote computing device that is communicatively coupled with the EHR," originally-filed and currently owned by Applicant in US 11,380,440, include neural network features not claimed in the instant case and rely on humans to carry out healthcare duties such as recommending medical tests, diagnosing and reviewing positive indicators of a medical patient.
Applicant further alleges that claim 1 includes additional elements and other elements that integrate the judicial exception purported by the Office into a particular context corresponding to a practical application, liken to Vanda Pharmaceuticals Inc., see pgs. 17-19 and 21 of Remarks – Examiner disagrees.
For clarity, “generating ... (a set of) recommendations, for an action to take regarding the particular patient and the breathing disorder” ... “communicating (a subset of) the recommendations ... to an asthma health care provider ... (for) one or more courses of a particular treatment ... to treat the breathing disorder” (See step 360 of Applicant’s Fig. 3) for prescribing medications like a inhaler is a problem that has already been solved and neither treats nor prevents disease progression. Also, unlike Vanda Pharmaceuticals Inc., no technology is implemented in recited claim 1 to affect a particular treatment of a medical condition. For example, no machine learning model with support, artificial intelligence (AI) decision making software, text recognition software or AI is being used to generate or communicate the recommendations. Furthermore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea.
Applicant alleges that claim 1 is Accessing a Model and Utilizing an Output of the Model, see pgs. 19-20 of Remarks – Examiner disagrees.
Again, the instant case does not specifically disclose how the machine learning is done so that a person of ordinary skill in the art could recognize that the applicant had possession of the claimed invention and actually invented how the machine learning model is applied in instances of prior selections of the prior recommendations made by users, associated with sets of recommendations and generating a subset of the recommendations.
Applicant alleges that the claims Improve in A Technology, see pgs. 20-21 of Remarks – Examiner disagrees.
Besides no written description of how: 1) the model training data selection process filters down recommendations-type training data in association with training the model, and 2) refraining from generating any recommendations that are consistent with the first protocol, no improvement in technology is explained. training a machine learning model using data associated with ... (the) recommendations ... and () instances of prior selections ...; inputting to the machine learning model information associated with the set of recommendations; generating a subset of the recommendations. Furthermore, the basic computer functions of integrating, applying, identifying, generating and updating when communicating treatment recommendations are not effecting upon the components of increasing processor speed and memory retrieval, but is rather performing basic data processing operations that any generic computer would be expected to do.
The amendments necessitate maintaining the 112(a) rejection. The Examiner has entered a new rejection under 35 USC § 112(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Springs WO 2021/067733 A1) & Allen (US 10,971,254 B2).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA S WILLIAMS whose telephone number is (571)270-5509. The examiner can normally be reached Mon-Fri, 8:30 am -6:30 pm.
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/T.S.W./Examiner, Art Unit 3687
05/23/2026
/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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