DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1-15 in the reply filed on February 6, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
Step 1: All of claims 1-15 are directed either to a method or to a system/machine.
Step 2A, Prong One: The claims recite a mental process including at least the steps “calculate sepsis scores … generate a sepsis score trend … generate a predicted sepsis trend …” seen in independent claims 1 and 9 which could be performed by the human mind and/or by a human with a physical aid such as pen and paper.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the step of “using … data captured by one or more sensors” is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process; the step of “display …” is considered insignificant post-solution activity since it merely outputs the result of the mental process using a generic output modality. Furthermore, merely carrying out mental steps using generic computing technology such as “at least one processing device … a memory device …” is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components and generic data collection and output components discussed in the step above. The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
Concerning dependent claims 2-4, 7-8, 10-12 and 14-15, these claims merely add further insignificant post-solution activity of displaying the results of the mental process using well-understood, routine and conventional display options.
Concerning dependent claim 5, this claim merely adds further mental steps, and thus follow the same analysis as the independent claims above.
Concerning dependent claims 6 and 13, these claims merely add further insignificant post-solution activity of generating an alert, and thus follows the same analysis above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-6, 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0202350 A1 to Sandgaard et al. (hereinafter “Sandgaard”) in view of US 2016/0239611 A1 to Heldt et al. (hereinafter “Heldt”).
Regarding Claims 1 and 9, A system for monitoring sepsis in a healthcare facility (see e.g. the abstract: “A system for monitoring sepsis …”), the system comprising:
at least one processing device (processing circuitry 108; see e.g. FIG. 1 and Para. 86); and
a memory device (memory 124; see e.g. FIG. 1 and Para. 86) storing instructions which, when executed by the at least one processing device (see e.g. Para. 92: “In one example, the processing circuitry includes one or more microprocessors that execute instructions stored on memory 124 and/or stored on other memory local to the processing circuitry 108. In general, the processing circuitry 108 controls the interactions between the elements of the system 100 and may perform one or more of the methods described herein”), cause the at least one processing device to:
calculate sepsis scores for a patient using physiological parameter data captured by one or more sensors (see e.g. FIGS. 10-11; also see e.g. Para. 127: “an algorithm for determining the sepsis index as derived from the combination of multiple physiological parameters which are, individually, indicators of sepsis, so as to produce a singular scoring mechanism for sepsis conditions in a patient”));
generate a sepsis score trend based on the sepsis scores (see e.g. FIG. 10);
Sandgaard’s sepsis score/index is itself predictive in nature, but Sandgaard fails to specifically teach “generate a predicted sepsis trend based on the sepsis scores and a treatment administered to the patient; and display the predicted sepsis trend over the sepsis score trend.”
Another reference, Heldt, teaches an analogous invention for sepsis care management in which the system can calculate a prediction for how a treatment will affect the patient’s ongoing sepsis condition (see generally Paras. 53-55) and continuously re-evaluate ongoing treatment (see generally Paras. 39-41). The modeling may use a variety of “predictive variables” including current and past diagnostic data (see Para. 48) as well as treatment administered to the patient (see e.g. Para. 48: “… fifth category of predictive variables is management data quantifying the actions and responses of the clinical team, i.e. data related to the presence or absence, the timing, and the quantity of specific therapies …”; also again see Paras. 53-55). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Sandgaard to also generate and display a predicted sepsis trend based on existing scores and treatment administered because it would predictably and advantageously allow a healthcare provider to see the likely trend of the patient’s condition, which would help evaluate whether the current treatment(s) are sufficient or need to be re-evaluated.
Regarding Claim 5, Sandgaard further teaches wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to: determine whether the patient is septic based on the sepsis scores (see e.g. Para. 83: “For example, a sepsis monitor may display the distinct state of sepsis in a patient out of the following: no sepsis, onset of sepsis, sepsis, septic shock”).
Regarding Claims 6 and 13, Heldt further teaches wherein the instructions, when executed by the at least one processing device, further cause the at least one processing device to: generate an alert when the sepsis score trend increases after a treatment start, or when the sepsis score trend does not decrease a predetermined period of time after the treatment start (see e.g. Paras. 39-41 and 61-62). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Sandgaard to generate an alert when the sepsis score trend increases after a treatment start, or when the sepsis score trend does not decrease a predetermined period of time after the treatment start because it would help a provider identify and re-evaluate ineffective treatments.
Claims 2-4, 7-8, 10-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sandgaard in view of Heldt as applied to claims 1 and 9 above, and further in view of US 2021/0177339 A1 to Colorafi et al. (hereinafter “Colorafi”).
Regarding Claims 2-4 and 10-12, Sandgaard as modified above monitors both the onset of sepsis and the start of treatment, as discussed in the rejections of claims 1 and 9 above, but fails to specifically teach adding visual markers and/or message boxes on the sepsis score trend to indicate clinical events, including onset of sepsis and treatment start.
Another reference, Colorafi, teaches a system for monitoring sepsis of multiple patients in which a display shows various data concerning the ongoing diagnosis and treatment of sepsis, including both visual markers and message boxes, and including a variety of clinical events including both onset of sepsis (“time zero”) and treatment start (see generally FIGS. 5-12 which show variations of the UI in different situations). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Sandgaard to include visual markers and/or message boxes on the sepsis score trend to indicate clinical events, including onset of sepsis and treatment start, because doing so would allow a healthcare provider to easily and quickly determine the overall status of one or more patients.
Concerning the exact manner of displaying the data, e.g. displaying markers or message boxes “on the sepsis score trend,” this would amount to a merely unpatentable aesthetic design choice. See MPEP § 2144.04(I). Here, Sandgaard as modified above possesses and displays all of the same data recited in the claims here, and thus the only difference is the particular aesthetic presentation and arrangement of that data, which itself is not a patentable distinction.
Regarding Claims 7-8 and 14-15, Sandgaard as modified above fails to specifically teach “display a summary including a sepsis status and a treatment status for each patient of a plurality of patients in the healthcare facility … wherein the sepsis statuses are displayed differently to indicate a severity of the sepsis status for each patient, and the treatment statuses are displayed differently to indicate whether a treatment has been administered or not for each patient.” Concerning the display of the severity of sepsis status, it is noted that Sandgaard teaches this for at least one patient in the form of the score/index (but not necessarily for multiple patients).
Another reference, Colorafi, teaches a system for monitoring sepsis of multiple patients in which a display shows various data concerning the ongoing diagnosis and treatment of sepsis of a plurality of patients in the healthcare facility (see generally FIGS. 5-12 which show variations of the UI in different situations). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Sandgaard display a summary including a sepsis status and a treatment status for each patient of a plurality of patients in the healthcare facility, wherein the sepsis statuses are displayed differently to indicate a severity of the sepsis status for each patient, and the treatment statuses are displayed differently to indicate whether a treatment has been administered or not for each patient, because it would advantageously provide the healthcare provider with a comprehensive overview of multiple patients and would thus help manage situations in which multiple patients have sepsis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
