DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted May 20, 2026. Claims 1, 6, 9 – 10, 20 – 22, and 28 are amended. Claims 1 – 31 are pending.
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
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.
Claims 1, 9, and 20 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 1, for example, recites “initiating vitals monitoring for the patient, via application of monitoring equipment to the patient that collects vitals measurements for the patient; and delivering oxygen treatment to the patient, via administration of pulse oxygen or continuous oxygen to the patient to deliver oxygen to the patient”. The claim recites collecting vital sign measurements, however, the vital sign measurement can be as simple as collecting a patient’s temperature. It is unclear where, or when, the oxygen treatment is to be delivered, and how it is related to the vital sign collection.
The rejection of Claims 1, 6, and 20 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. are withdrawn based upon the amendment submitted May 20, 2026
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 – 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step One
Claims 1 – 31 are drawn to a method, non-transitory media, and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1, 9, and 20 recite predicting medication induced respiratory depression comprising: monitoring, over a time period and prior to an intervention, event logs for a set of trigger events wherein monitoring the event logs for the set of trigger events comprises: receiving, from a clinical workflow that contains the event logs, an indication of an instantiated instance of an event in the clinical workflow; identifying and autonomously in response to the monitoring, a trigger event of the set of trigger events indicative of an admission event, a diagnosis event, a clinical event, or an order event corresponding the admission event, the diagnosis event, or the clinical event and to a patient; performing a set of multiple operations and autonomously in response to the identifying, wherein the performing the set of multiple operations is performed without user intervention and comprise: querying at least one of a record or workflow corresponding to the patient for a presence of one or more of a plurality of predefined data elements to identify at least a subset of predefined data elements, of the plurality of predefined data elements, within at least one of the record or workflow; based on values, assigned to each of the subset of predefined data elements within the at least one of the record or workflow, determining a representative element value of the patient; determining whether the representative element value meets a threshold; and in response to the representative element value being determined to meet the threshold, generating an information item, wherein the information item includes the representative element value and an instruction that corresponds to the intervention and is based on the total representative value; initiating vitals monitoring for the patient, via application of monitoring equipment to the patient that collects vitals measurements for the patient; and delivering oxygen treatment to the patient, via administration of pulse oxygen or continuous oxygen to the patient.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that “the present disclosure relates to a method for predicting medication induced respiratory depression” (see: specification paragraph 4). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims present collected and analyzed data to a user, with instructions. Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “computer implemented”, “one or more hardware processors”, “computerized”, “medical-information computing system”, “electronically”, “automatically”, “electronic”, “electronically transmitting”, “electronic interface”,
Claims 2 – 8, 23 – 29, 31: “computer implemented”
Claim 9: “computer storage device”, “non-transitory computer-readable media”, “program instructions, written on the one or more non-transitory computer readable media, when executed by one or more processors, cause the one or more processors to perform a plurality of operations”, “one or more hardware processors”, “medical-information computing system”, “computerized”, “electronically”, “automatically”, “electronic”, “electronically transmitting”, “electronic interface”
Claim 10: “computer storage device”, “electronic”
Claims 11 – 14, 16 – 17: “computer storage device”
Claim 15: “computer storage device”, “transmitting”, “automatically”, “clinician device”
Claims 18 – 19: “computer storage device”, “electronic”, “automatically”
Claim 20: “computer system”, “one or more hardware processors”, “program instructions, written on the one or more non-transitory computer readable media, when executed by one or more processors, cause the one or more processors to perform a plurality of operations”, “computerized”, “medical-information computing system”, “electronically”, “automatically”, “electronic”, “electronically transmitting”, “electronic interface”
Claim 21: “computer implemented”, “scan”, “electronic”
Claim 22: “computer implemented”, “one or more hardware processors”
Claim 30: “computer implemented”, “electronic”
These features are additional elements that are recited at a high level of generality (e.g., the “non-transitory media having instructions that, when executed by one or more processors, cause the one or more processors to facilitate a plurality of operations” is no more than a statement that said instructions are executed) such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed (e.g., the ““non-transitory computer-readable storage medium having instructions embodied thereon, the instructions being executable by one or more processors to perform” language is incidental to what instructions are executed). Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even 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.
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
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 integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0023] Beginning with FIG. 1, a computing environment 100 that is suitable for use in implementing aspects of the present invention is depicted. The computing environment 100 is merely an example of one suitable computing environment and is not intended to suggest any limitation as to the scope of use or functionality of the invention. Neither should the computing environment 100 be interpreted as having any dependency or requirement relating to any single component or combination of components illustrated therein. Generally, in aspects, the computing environment 100 is a medical-information computing-system environment. However, this is just one example and the computing environment 100 can be operational with other types, other kinds, or other-purpose computing system environments or configurations. Examples of computing systems, environments, and/or configurations that might be suitable for use with the present invention include personal computers, server computers, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, set top boxes, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above-mentioned systems or devices, and the like.
[0040] Turning now to FIGS. 2 and 3, methods are discussed that can be performed via one or more of the devices, components, and/or component interactions previously described in FIG. 1. It should be understood that the methods discussed herein can be implemented or performed via the execution of non-transitory computer-readable instructions and/or executable program code portions stored on computer readable media, using one or more processors. The computer-readable program code can correspond to the application, described above, wherein the application performs the methods, in some aspects. In aspects, the methods can be implemented and performed using a computerized application. As such, the methods can be computer-implemented methods, in some aspects, integrated with and executed to complement a computerized clinical workflow.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 8, 10 – 19, and 21 – 31 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
The rejection of Claim(s) 1 – 2, 4, 8 – 11, 14 – 27, and 29 – 31 under 35 U.S.C. 103 as being unpatentable over Meger et al., herein after Meger (U.S. Publication Number 2024/0008751 A1) i in view of McCallie, Jr. et al., herein after McCallie (U.S. Patent Number 8,239,216 B2) further in view of Joseph et al., herein after Joseph (U.S. Publication Number 2020/0352456 A1) are withdrawn based upon the amendment submitted May 20, 2026.
The rejection of Claim(s) 3 under 35 U.S.C. 103 as being unpatentable over Meger et al., herein after Meger (U.S. Publication Number 2024/0008751 A1) in view of McCallie, Jr. et al., herein after McCallie (U.S. Patent Number 8,239,216 B2) further in view of Joseph et al., herein after Joseph (U.S. Publication Number 2020/0352456 A1) further in view of Jolley et al., herein after Jolley (Jolley, R. J., Liang, Z., Peng, M., Pendharkar, S. R., Tsai, W., Chen, G., Eastwood, C. A., Quan, H., & Ronksley, P. E. (2018). Identifying cases of sleep disorders through International Classification of Diseases (ICD) Codes in administrative data. International Journal of Population Data Science, 3(13), 1-11. http://dx.doi.org/10.23889/ijpds.v3i1.448) is withdrawn based upon the amendment submitted May 20, 2026.
The rejection of Claim(s) 5 and 28 under 35 U.S.C. 103 as being unpatentable over Meger et al., herein after Meger (U.S. Publication Number 2024/0008751 A1) in view of McCallie, Jr. et al., herein after McCallie (U.S. Patent Number 8,239,216 B2) further in view of Joseph et al., herein after Joseph (U.S. Publication Number 2020/0352456 A1) further in view of Freeman et al., herein after Freeman (U.S. Publication Number 2018/0098739 A1) is withdrawn based upon the amendment submitted May 20, 2026.
The rejection of Claim(s) 6 – 7 and 12 – 13 under 35 U.S.C. 103 as being unpatentable over Meger et al., herein after Meger (U.S. Publication Number 2024/0008751 A1) in view of McCallie, Jr. et al., herein after McCallie (U.S. Patent Number 8,239,216 B2) further in view of Joseph et al., herein after Joseph (U.S. Publication Number 2020/0352456 A1) further in view of Taube (U.S. Publication Number 2008/0183057 A1) are withdrawn based upon the amendment submitted May 20, 2026.
Response to Arguments
Applicant's arguments filed May 20, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Rejections under 35 USC § 101
The Applicant argues the present claims do not fail within the abstract-idea grouping of certain methods of organizing human activity. The Examiner disagrees. Under its broadest reasonable interpretation, the Applicant’s claims are an abstract idea that falls into the grouping of “Certain Methods of Organizing Human Activity” which covers fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people. The Examiner respectfully submits that the PEG (Patent Eligibility Guidelines) of January 2019 recite that “Certain Methods of Organizing Human Activity” include managing personal behavior or relationships or interactions between people, including social activities, teaching, and following rules or instructions. The present claims recite the abstract idea of predicting medication induced respiratory depression. The present claims recite predicting medication induced respiratory depression comprising: monitoring, over a time period and prior to an intervention, a first set of information or a set of trigger events that are associated with data and corresponds to one or both of a clinical record and a clinical workflow; identifying and autonomously in response to the monitoring, a trigger event of the set of trigger events indicative of an admission event, a diagnosis event, a clinical event, or an order event corresponding the admission event, the diagnosis event, or the clinical event and to a patient, performing a set of multiple operations and autonomously in response to the identifying, wherein the performing the set of multiple operations is performed without user intervention and comprise: querying at least one of a record or workflow corresponding to the patient for a presence of one or more of a plurality of predefined data elements to identify at least a subset of predefined data elements, of the plurality of predefined data elements, within at least one of the record or workflow; based on values, assigned to each of the subset of predefined data elements within the at least one of the record or workflow, determining a representative element value of the patient; determining whether the representative element value meets a threshold; and in response to the representative element value being determined to meet the threshold, generating an information item, wherein the information item includes the representative element value and an instruction that corresponds to the intervention and is based on the total representative value. These features describe interactions with people by providing notice information and instructions based on the total element result to a user or clinician (see paragraph 5 of the published specification), thus “Certain Methods of Organizing Human Activity”. Thus, if a claim limitation, under its broadest reasonable interpretation, covers interactions with people, but for the recitation of generic components, then it is still in the “Certain Methods of Organizing Human Activity” grouping.
The Applicant argues the additional and other elements of the claims 1 integrates any judicial exception into a practical application including hardware electronic microprocessors creating unique data elements, generating notice information from analyzing the uniquely created information, and transmitting the notice information to an electronic interface. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
The Applicant argues claim 1 recites significantly more than the judicial exception. The Examiner respectfully disagrees. The Applicant’s specification states
“Beginning with FIG. 1, a computing environment 100 that is suitable for use in implementing aspects of the present invention is depicted. The computing environment 100 is merely an example of one suitable computing environment and is not intended to suggest any limitation as to the scope of use or functionality of the invention. Neither should the computing environment 100 be interpreted as having any dependency or requirement relating to any single component or combination of components illustrated therein. Generally, in aspects, the computing environment 100 is a medical-information computing-system environment. However, this is just one example and the computing environment 100 can be operational with other types, other kinds, or other-purpose computing system environments or configurations. Examples of computing systems, environments, and/or configurations that might be suitable for use with the present invention include personal computers, server computers, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, set top boxes, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above-mentioned systems or devices, and the like.” (paragraph 23 of the published specification). The generic computer cited by the Applicant is a general link to execute the abstract idea. The processors, as used in the recited claims, is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
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 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 KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.K.R/Examiner, Art Unit 3682
/ROBERT A SOREY/Primary Examiner, Art Unit 3682
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