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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 335. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
*Reference character 335 was mentioned in Par. [0110] of the Applicant’s specification, but it is not included in Fig. 3.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 315. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
*Reference character 315 is shown in Fig. 3, but it is not included in the Applicant’s specification. The Examiner believes mention of ref. char. 315 was intended to be mentioned in Par. [0107].
Specification
The disclosure is objected to because of the following informalities:
Abstract, lines 1-2: “Novel tools and techniques are provided for detecting and differentiating sepsis are provided” should be amended. Please removed either the first or second instance of “are provided.
Par. [0037], lines 3-4: “sensor(s) 110, and/or sensor(s) 125” should be amended. Please remove “and/or sensor(s) 125”.
Par. [0037], line 7: “the sensor(s) 110, and/or the sensor(s) 125” should be amended. Please remove “and/or sensor(s) 125”.
Par. [0038], line 3: “sensor(s) 110, and/or sensor(s) 125” should be amended. Please remove “and/or sensor(s) 125”.
Par. [0050], line 4 (Eq. 1): The Examiner believes a minus (“-“) sign was intended to be included after the “1” in order to make the statements of Par. [0051] to be true. Therefore, it is believed that equation 1 is supposed to be read as:
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Par. [0052], lines 1-2: “is individual specific varies from person to person” should be changed to “is individual and varies from person to person”.
“Par. [0120], line 7: “used to normalized” should be changed to “used to normalize”.
Par. [0127], line 6: “sensor devices 105 and 310” should be changed to “sensor devices 105 and 210”.
Par. [0127], line 7: “monitoring computer 305” should be removed.
Par. [0127], line 8: “therapeutic devices 215 and 315” should be changed to “therapeutic devices 215”. Please removed “and 315”.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 17: “comprises a plurality waveforms” should be changed to “comprises a plurality of waveforms”. Please add “of”.
Line 19: “to the each of the plurality of waveforms” should be changed to “to each of the plurality of waveforms”. Please remove the first “the”.
Claim 7 objected to because of the following informalities:
Line 6: “the least severe” should be changed to “least severe”. Please remove “the”.
Claim 9 objected to because of the following informalities:
Line 4: The Examiner believes a minus (“-“) sign was intended to be included after the “1”. Therefore, it is believed that the equation is supposed to be read as:
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Claim 10 objected to because of the following informalities:
Line 7: “a user” should be changed to “a patient” to be consistent with the rest of claim 10.
Lines 26-27: “to the each of the plurality of waveforms” should be changed to “to each of the plurality of waveforms”. Please remove the first “the”.
Line 33: “determine based on the hemodynamic parameter” should be changed to “determine, based on the hemodynamic parameter”. Please add comma.
Claim 15 objected to because of the following informalities:
Line 7: “the least severe” should be changed to “least severe”. Please remove “the”.
Claim 16 objected to because of the following informalities:
Line 5: The Examiner believes a minus (“-“) sign was intended to be included after the “1”. Therefore, it is believed that the equation is supposed to be read as:
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Claim 17 objected to because of the following informalities:
Line 16: “a hemodynamic parameter” should be changed to “determine, a hemodynamic parameter”. Please add “determine,” to the beginning of line 16.
Lines 30-31: “a plurality waveforms” should be changed to “a plurality of waveforms”. Please add “of”.
Lines 33-34: “to the each of the plurality of waveforms” should be changed to “to each of the plurality of waveforms”. Please remove the first “the”.
Claim 20 objected to because of the following informalities:
Line 5: “a dosage” should be changed to “the dosage”. Note: It is believed that claim 20 was intended to depend from claim 19 (see 35 U.S.C. 112(b) rejection below). If this change is made, “a dosage” will need to be changed to “the dosage” since “a dosage” was introduced in claim 19.
Claim 21 objected to because of the following informalities:
Line 7: “the least severe” should be changed to “least severe”. Please remove “the”.
Claim 22 objected to because of the following informalities:
Line 5: The Examiner believes a minus (“-“) sign was intended to be included after the “1”. Therefore, it is believed that the equation is supposed to be read as:
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Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“hemodynamic model” in claims 1, 10, and 17.
“sepsis model” in claims 1, 10, and 17.
“fluid responsivity model” in claims 2, 11, and 18.
“treatment effectiveness model” in claims 3, 12, and 19.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner notes that for a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function (MPEP 2181(II)(B)). Evidence of such an algorithm for covering the corresponding structure, material, or acts are found in these locations of the specification:
Par. [0040-0042], [0055], [0095-0096], [0105], [0115] – model may be derived empirically or by using artificial learning/machine learning algorithms
Par. [0040-0042], [0057-0059], [0095-0096], [0105], [0114-0115] – model may be derived empirically or by using artificial learning/machine learning algorithms
Par. [0040-0042], [0065], [0095-0096], [0105], [0115] – model may be derived empirically or by using artificial learning/machine learning algorithms
Par. [0040-0042], [0069], [0095-0096], [0105], [0115] – model may be derived empirically or by using artificial learning/machine learning algorithms
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-22 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 recites the limitation “physiological data” in line 5, whereas physiological data was already introduced in claim 1 (lines 3-4). It is unclear whether the Applicant intended to claim the same or a different physiological data. Consider changing to “the physiological data”.
Claim 1 recites the limitation "the patient’s proximity to hemodynamic decompensation" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “a patient” in line 11, whereas a patient was already introduced in claim 1 (line 4). It is unclear whether the Applicant intended to claim the same or a different patient. Consider changing to “the patient”.
Claim 1 recites the limitation “sepsis model” in line 32, whereas a septic model was already introduced in claim 1 (line 27). It is unclear whether the Applicant intended to claim the same or a different sepsis model. Consider changing to “the sepsis model”.
Claim 3 recites the limitation “hemodynamic parameter” in line 9, whereas a hemodynamic parameter was already introduced in a claim that claim 3 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different hemodynamic parameter. Consider changing to “the hemodynamic parameter”.
Claim 4 recites the limitation “a dosage” in line 4, whereas a dosage was already introduced in a claim that claim 4 depends from (claim 3, line 11). It is unclear whether the Applicant intended to claim the same or a different dosage. Consider changing to “the dosage”.
Claim 10 recites the limitation “physiological data” in line 9, whereas physiological data was already introduced in claim 10 (line 7). It is unclear whether the Applicant intended to claim the same or a different physiological data. Consider changing to “the physiological data”.
Claim 10 recites the limitation "the patient" in line 11. There is insufficient antecedent basis for this limitation in the claim. Please consider changing “a user” in line 7 to “a patient”.
Claim 10 recites the limitation "the patient’s proximity to hemodynamic decompensation" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “a patient” in line 16, whereas a patient was already introduced in claim 10. It is unclear whether the Applicant intended to claim the same or a different patient. Consider changing to “the patient”.
Claim 10 recites the limitation “sepsis model” in line 42, whereas a sepsis model was already introduced in claim 10 (line 36). It is unclear whether the Applicant intended to claim the same or a different sepsis model. Consider changing to “the sepsis model”.
Claim 13 recites the limitation “a dosage” in line 5, whereas a dosage was already introduced in a claim that claim 13 depends from (claim 12). It is unclear whether the Applicant intended to claim the same or a different dosage. Consider changing to “the dosage”.
Claim 17 recites the limitation “physiological data” in line 4, whereas physiological data was already introduced in claim 17 (line 2). It is unclear whether the Applicant intended to claim the same or a different physiological data. Consider changing to “the physiological data”.
Claim 17 recites the limitation “one or more sensors” in line 12, whereas one or more sensors was already introduced in claim 17 (line 2). It is unclear whether the Applicant intended to claim the same or a different one or more sensors. Consider changing to “the one or more sensors”.
Claim 17 recites the limitation “physiological data” in line 13, whereas physiological data was already introduced in claim 17 (line 2). It is unclear whether the Applicant intended to claim the same or a different physiological data. Consider changing to “the physiological data”.
The limitation “a user” renders claim 17 (line 13) indefinite. It is unclear whether a user is the same as “a patient” that was introduced earlier in claim 17 (line 2). Please consider changing to “the patient”.
Claim 17 recites the limitation “non-invasively obtained waveforms of physiological data” in lines 14-15, whereas non-invasively obtained waveforms of physiological data was already introduced in claim 17 (lines 3-4). It is unclear whether the Applicant intended to claim the same or a different non-invasively obtained waveforms of physiological data. Consider changing to “the non-invasively obtained waveforms of physiological data”.
Claim 17 recites the limitation "the patient’s proximity to hemodynamic decompensation" in lines 18-19. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation “a patient” in lines 21-22, whereas a patient was already introduced in claim 17 (line 2). It is unclear whether the Applicant intended to claim the same or a different patient. Consider changing to “the patient”.
Claim 17 recites the limitation “sepsis model” in line 52, whereas a sepsis model was already introduced in claim 17 (line 45). It is unclear whether the Applicant intended to claim the same or a different sepsis model. Consider changing to “the sepsis model”.
Claim 20 recites the limitation "the therapeutic agent" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Examiner believes claim 20 was intended to depend from claim 19.
Claim 20 recites the limitation "the treatment effectiveness value" in line 3. There is insufficient antecedent basis for this limitation in the claim.
*Note: All other claims rejected due to their dependency on a rejected claim.
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 1-3, 5-12, 14-19, and 21-22 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of obtaining data, analyzing it, and outputting a result of the analysis) without significantly more.
Step 1
Independent claims 1, 10, and 17 are directed to a method and apparatus, and thus meets the requirements of step 1.
Step 2A, Prong 1
Regarding claims 1, 10, and 17, the following steps recite an abstract idea
“determining, based on the physiological data, a hemodynamic parameter of the patient” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could determine a hemodynamic parameter of a patient when provided with physiological data.
“applying a hemodynamic model to the physiological data” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could apply a hemodynamic model (e.g., such as a mental understanding of physiological measurements that correspond to particular hemodynamic parameters) to the physiological data.
“comparing one or more waveforms of the physiological data of the patient to the each of the plurality of waveforms of reference data” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could compare waveforms of physiological data to waveforms of reference data.
“determining the hemodynamic parameter of the patient based on the comparison to each of the plurality of waveforms of reference data” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make a determination of a hemodynamic parameter based on the comparison to the waveforms of reference data.
“determining based on the hemodynamic parameter of the patient over the first time period, whether the patient is septic” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make a determination of whether the patient is septic based on the hemodynamic parameter of the patient.
“applying a sepsis model to the hemodynamic parameter of the patient over the first time period” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could apply a sepsis model (e.g., such as a mental understanding of hemodynamic parameters that correspond to particular sepsis determinations) to the physiological data.
“comparing the waveform of the hemodynamic parameter over the first time period to each of the plurality of reference waveforms of the hemodynamic parameter” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could compare the waveform of the hemodynamic parameter to each of the reference waveforms of the hemodynamic parameter.
“determining whether the patient is septic based on the sepsis value of the patient” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make a determination of whether the patient is septic based on the sepsis value of the patient.
“displaying at least one of the hemodynamic parameter of the patient and a determination of whether the patient is septic” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could display/output (e.g., in writing, by drawing, by communication) the hemodynamic parameter of the patient and the determination of whether the patient is septic.
Step 2A – Prong 2
Regarding claims 1, 10, and 17, the claims do not include any additional elements that integrate the abstract idea into a practical application. The following elements do not add any meaningful limitation to the abstract idea:
“a sensor device”, “a computer system”, a “processor”, and “a display screen of a user device” are all recited with a high level of generality. The sensor device is recited at a high level of generality as the Applicant explains in Par. [0031] of the instant specification that the one or more sensors may include skin temperature sensors, electrodermal activity (EDA) sensors, thermometers, pulse oximeters, blood pressure sensors, respiration rate monitors, heart rate monitors, fluid intake sensors, electrocardiographs, optical sensors, or other sensors suitable to capture waveforms generated by the patient during the cardiac cycle. The “sensor device” is insignificant extra-solution activity in that it is merely used to gather and collect data [MPEP 2106.05(b) and (g)]. The involvement of “obtaining physiological data op a patient continuously over a first time period” is considered insignificant extra-solution activity in that it is merely involved with gathering and collecting data [MPEP 2106.05(g)].
The computer system, processor, and display screen of a user device are recited with a high level of generality. The Applicant explains in Par. [0098] of the instant specification that the computer system may be any system of one or more computers that are capable of performing the techniques described within the specification. The Applicant explains in Par. [0128] of the instant specification that the one or more processors may include one or more general-purpose processors and/or one or more special-purpose processors (such as microprocessors, digital signal processing chips, graphics acceleration processors, and/or the like). The Applicant explains in Par. [0036] that the user device(s) may include a smart phone, smart watch, tablet computer, laptop computer, desktop computer, or dedicated sensor controller, and/or the like. The involvement of the “computer system”, “processor”, and “display screen of a user device” is insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)]. It is also noted that the involvement of the hemodynamic model, sepsis model, fluid responsivity model, and treatment effectiveness model can be derived empirically or by using artificial intelligence/machine learning algorithms (see 35 U.S.C. 112(f)/claim interpretation section above), which would also be considered insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)].
Furthermore, the “sensor device”, “computer system”, “processor”, and “display screen of a user device”, along with their associated functions and components, do not add any meaningful limitation to the abstract idea when considered in combination because these elements are recited at a high level of generality and their related functions and components are merely implementing the abstract idea on a computer.
Step 2B
The additional elements of claims 1, 10, and 17, when considered either individually or in an ordered combination, are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the “sensor device”, “computer system”, “processor”, and “display screen of a user device”, along with their associated functions and components are recited with a high level of generality and simply amount to collecting/gathering data and implementing the abstract idea on a computer. The additional elements that were considered insignificant extra-solution activity have been re-analyzed and do not amount to anything more than wat is well-understood, routine, and conventional. Also, simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not indicative of an inventive concept [MPEP 2106.05(d)]. Andre, et al. (U.S. PGPub No. 2012/0245439) explains that methods for generating data indicative of various physiological parameters and sensors to be used therefore are well known (Par. [0087]). Lee, et al. (U.S. PGPub No. 2020/0176117) also evidences that machine learning is generally found to be conventional (Par. [0083]). Guha (U.S. Patent No. 5,808,609) discuss and evidence that computer systems, processors, and displays are conventional and well-known (Col. 1, lines 12-23; Col. 2, lines 8-25; Col. 10, line 64-Col. 11, line 3). In this case, well-known elements of a general computer system and well-known elements for data collection/analysis are used to implement are used to implement the abstract idea of obtaining data, analyzing it, and outputting a determination of whether the patient has sepsis. Also, generally linking the use of the judicial exception to the field of sepsis determination is not indicative of an inventive concept [MPEP 2106.05(h)].
Dependent claims
Regarding dependent claims 2-3, 5-9, 11-12, 14-16, 18-19, and 21-22, the limitations only further define the abstract idea.
Therefore, claims 1-3, 5-12, 14-19, and 21-22 are unpatentable under 35 U.S.C. 101.
*The Examiner notes that implementing the limitation of instant claims 4, 13, and 20 into independent claims 1, 10, and 17, respectively, would overcome the 35 U.S.C. 101 rejections. This is because the limitation of instant claims 4, 13, and 20 “wherein the controlling the therapeutic device includes adjusting at least one of a dosage of the therapeutic agent or a volume of fluid administered to the patient” is sufficient to amount to significantly more than the abstract idea judicial exception. This limitation is directed to an active treatment step (i.e., adjusting a dosage of the therapeutic agent or a volume of fluid administered to the patient) that occurs based on the determined treatment effectiveness value.
Allowable Subject Matter
Claims 1-22 contain potentially allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record (namely Winslow, et al. (U.S. PGPub No. 2020/0176115) and Norman, et al. (U.S. PGPub No. 2022/0211331)) does not disclose or fairly suggest either singly or in combination the claimed invention of independent claims 1, 10, and 17 when taken as a whole, comprising, in addition to the other recited claim elements, obtaining, with one or more sensors disposed in a sensor device, physiological data of a patient continuously over a first time period, the physiological data comprising non-invasively obtained waveforms of physiological data;
determining, via a computer system, based on the physiological data, a hemodynamic parameter of the patient over the first time period, wherein the hemodynamic parameter is a patient-specific indication of the patient's proximity to hemodynamic decompensation at a given time, wherein the hemodynamic parameter is a numerical value indicating a relationship between an intravascular volume loss of a patient at the given time and an intravascular volume loss at hemodynamic decompensation of the patient,
wherein determining the hemodynamic parameter of the patient comprises:
applying a hemodynamic model to the physiological data, the hemodynamic model relating the physiological data to the hemodynamic parameter, wherein the hemodynamic model comprises a plurality waveforms of reference data;
comparing one or more waveforms of the physiological data of the patient to the each of the plurality of waveforms of reference data, each of the plurality of waveforms of reference data corresponding to a respective value of the hemodynamic parameter;
determining the hemodynamic parameter of the patient based on the comparison to each of the plurality of waveforms of reference data;
determining, via the computer system, based on the hemodynamic parameter of the patient over the first time period, whether the patient is septic, wherein determining whether the patient is septic further comprises:
applying a sepsis model to the hemodynamic parameter of the patient over the first time period, wherein the hemodynamic parameter over the first time period is a waveform of the hemodynamic parameter of the patient, the sepsis model relating waveforms of the hemodynamic parameter to a sepsis value representing whether the patient is septic, wherein sepsis model comprises a plurality of reference waveforms of the hemodynamic parameter;
comparing the waveform of the hemodynamic parameter over the first time period to each of the plurality of reference waveforms of the hemodynamic parameter, each of the plurality of reference waveforms of the hemodynamic parameter corresponding to a respective sepsis value; and
determining whether the patient is septic based on the sepsis value of the patient; and
displaying, on a display screen of a user device, at least one of the hemodynamic parameter of the patient and a determination of whether the patient is septic.
No other prior art reference could be found that teaches or renders obvious the limitations of instant claims 1, 10, and 17. Due to their dependency on independent claims 1, 10, and 17, instant claims 2-9, 11-16, and 18-22 are also considered to contain allowable subject matter.
Therefore, in view of the prior art and its deficiencies, the claimed invention as a whole is rendered novel and non-obvious, and thus, is allowable as claimed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Specifically, 35 U.S.C. 101 and 112(b) rejections must be overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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.
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/MICHAEL T. HOLTZCLAW/Examiner, Art Unit 3796