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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 October 2025 has been entered.
Claims 5-9, 14-18 and 21 are cancelled; claims 22-25 are withdrawn; new claims 26-27 are entered; claims 1-4,10-13, 19-20 and 26-27 are pending.
Election/Restrictions
Applicant's traverse of the election by original presentation in the reply filed on 17 October 2025 is acknowledged. The traversal is on the ground(s) that “these claims overlap in subject matter with the already examined claims such that there is no serious burden to also examine claims 22-25”. This is not found persuasive because the inventions are patentably distinct for the reasons outlined in the Final Rejection.
The requirement is still deemed proper and is therefore made FINAL.
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 26-27 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The Examiner has searched the Disclosure as originally filed, and found numerous examples of the coefficient, but no explicit disclosure that the coefficient is an integer, nor that it is above or below zero as required by the newly submitted claims. For example, the coefficient is, in par. 0133-0134 of the Published Application, given as an example to be 240. The Examiner notes that this is an integer, and one that is above zero. There is no explanation as to how that integer was selected, nor why it is an integer above zero. The terms “zero” or “integer” do not appear in the Specification. Therefore, the limitations that the coefficient should be an integer and either positive or negative necessarily are not supported by the original application, nor would they be understood by one of ordinary skill in the art as inherent to the operation of a similar device at the time of the invention.
Double Patenting
Applicant’s arguments, see “Remarks”, filed 17 October 2025, with respect to the abandonment of application 17/566,275 have been fully considered and are persuasive. The rejection of claims 1 and 12 has been withdrawn.
Response to Arguments
Applicant's arguments filed 17 October 2025 have been fully considered but they are not persuasive. The Applicant argues (page 10, “Remarks”):
Applicant fails to see how the above discussion in Newberry reasonably discloses or suggests "determining a difference between a first physiological parameter of the one or more physiological parameters measured at a first time and the first physiological parameter measured at a second time," and "multiplying the difference by a coefficient associated with the first physiological parameter to generate an impact value," and then "determining an index value by adding the impact value to a base index value," with "the base index value being determined by baseline values for the one or more physiological parameters specific to the patient," and where "the processing circuitry determines the sepsis state for the patient based on the index value," as recited in claim 1. For example, even assuming arguendo that a difference between a measured R value and a baseline R value is equated to the claimed difference, Newberry does not disclose or suggest multiplying such a difference between R values by another value, let alone disclose multiplying that difference by "a coefficient associated with the first physiological parameter to generate an impact value," and then "determining an index value by adding the impact value to a base index value," as recited in claim 1.
The Examiner respectfully disagrees with this assessment of Newberry. The Applicant relies upon only one of the citations provided by the Examiner in the previous Office Action. In previously cited. Col. 23, lines 35-59, Newberry discloses:
The NO measurement of the nitric oxide is compared to a first predetermined threshold. For example, normal ranges of the NO measurement from the baseline measurement are determined for septic risk. Patient vitals may also be compared to predetermined thresholds Depending on the comparison, one or more warnings are displayed. For example, the first predetermined threshold may be when the NO measurement has exceeded at least 10% of the baseline level of the NO measurement. A warning is displayed to indicate a health alert at 1810. A caregiver may then perform other tests to determine the cause of the elevated NO measurement, such as lactic acid blood test for sepsis.
The biosensor continues to monitor the NO measurement in blood vessels and compare the NO measurement to one or more predetermined thresholds. In 1812, it is determined that the NO measurement has exceeded a second predetermined threshold. For example, the NO measurement equals or exceeds at least 30% of a baseline level of the NO measurement. A warning to indicate a medical emergency is displayed at 1814. Due to the immediate danger of such high levels of NO measurement and dangers of septic shock, a request for immediate emergency treatment may be indicated. Though 10% and 30% are illustrated in this example, other percentages over the baseline level may also trigger warnings or alerts.
The Examiner considers this to anticipate the invention as claimed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 10-13 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newberry (U.S. 9,968,289). Newberry discloses (Figure 2) one or more sensors (100) that noninvasively monitor a patient to produce sensor data (col. 8, lines 5-15); processing circuitry (202) to: derive, from the sensor data, one or more physiological parameters of the patient that are indicative of a sepsis state of the patient; apply a set of rules to the one or more physiological parameters; determine a sepsis state for the patient based on the set of rules applied to the one or more physiological parameters; and output at least one electronic signal indicative of the sepsis state of the patient; and an output device (106) that outputs a notification based on the at least one electronic signal (col. 8, lines 43-56), wherein the processing circuitry is configured to apply the set of rules by (col. 23, lines 35-59): determining a difference between a first physiological parameter of the one or more physiological parameters measured at a first time and the first physiological parameter measured at a second time; multiplying the difference by a coefficient associated with the first physiological parameter to generate an impact value; and determining an index value by adding the impact value to a base index value, the base index value being determined by baseline values for the one or more physiological parameters specific to the patient, wherein the processing circuitry determines the sepsis state for the patient based on the index value (col. 28, lines 47-59).
Regarding claim 2, Newberry discloses (col. 8, lines 43-56) the one or more sensors include a heart rate sensor, a temperature sensor, and a respiration rate sensor, and wherein the one or more physiological parameters of the patient include heart rate monitored by the heart rate sensor, temperature monitored by the temperature sensor, and respiration rate monitored by the respiration rate sensor.
Regarding claim 3, Newberry discloses (col. 8, lines 43-56) the output device includes a display that displays the notification to indicate the sepsis state of the patient.
Regarding claim 4, Newberry discloses (col. 25, lines 20-33) the sensor data comprises a first signal, and wherein the processing circuitry is configured to: measure one or more signal characteristics of the first signal during a first time period; measure the one or more signal characteristics of the first signal during a second time period; measure the one or more signal characteristics of the first signal during a third time period, wherein the first time period is between the second time period and the third time period determine that the first signal contains an unreliable signal portion when the one or more signal characteristics measured during the first time period do not sufficiently match the one or more signal characteristics measured during the second time period and the third time period; and discard the unreliable signal portion to yield a reliable signal portion of the first signal from which the first physiological parameter is derived.
Regarding claim 10, Newberry discloses (col. 19, lines 32-47) a value of the coefficient is based on a reliability of the first physiological parameter in predicting the sepsis state.
Regarding claim 11, Newberry discloses (col. 19, lines 32-47) the value of the coefficient varies as the reliability of the first physiological parameter in predicting the sepsis state changes.
Regarding claim 12, Newberry discloses (Figure 2) processing circuitry (202) to: derive, from sensor data of one or more noninvasive sensors (100), one or more physiological parameters of a patient that are indicative of a sepsis state of the patient (col. 8, lines 5-15); apply a set of rules to the one or more physiological parameters; determine a sepsis state for the patient based on the set of rules applied to the one or more physiological parameters; and output at least one electronic signal (col. 8, lines 43-56) that causes a display to display a visual indication of the sepsis state of the patient, wherein the processing circuitry applies the set of rules by (col. 23, lines 35-59): determining a difference between a first physiological parameter of the one or more physiological parameters measured at a first time and the first physiological parameter measured at a second time; multiplying the difference by a coefficient associated with the first physiological parameter to generate an impact value; and determining an index value by adding the impact value to a base index value, the base index value being determined by baseline values for the one or more physiological parameters specific to the patient, wherein the processing circuitry determines the sepsis state for the patient based on the index value (col. 28, lines 47-59).
Regarding claim 13, Newberry discloses (col. 25, lines 20-33) the sensor data comprises a first signal, and wherein the processing circuitry is configured to: measure one or more signal characteristics of the first signal during a first time period; measure the one or more signal characteristics of the first signal during a second time period measure the one or more signal characteristics of the first signal during a third time period, wherein the first time period is between the second time period and the third time period determine that the first signal contains an unreliable signal portion when the one or more signal characteristics measured during the first time period do not sufficiently match the one or more signal characteristics measured during the second time period and the third time period; and discard the unreliable signal portion to yield a reliable signal portion of the first signal from which the first physiological parameter is derived.
Regarding claim 19, Newberry discloses (col. 19, lines 32-47) a value of the coefficient is based on a reliability of the first physiological parameter in predicting the sepsis state.
Regarding claim 20, Newberry discloses (col. 19, lines 32-47) the value of the coefficient varies as the reliability of the first physiological parameter in predicting the sepsis state changes.
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.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Newberry (U.S. 9,968,289). Newberry discloses the claimed invention but does not disclose expressly the coefficient is an integer. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the percentage multiplier as taught by Newberry, with the integer coefficient, because the applicant has not disclosed the integer coefficient provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with the percentage coefficient as taught by Newberry, because Newberry is able to determine an index value for monitoring sepsis as in the claimed invention. Therefore, it would have been an obvious matter of design choice to modify Newberry’s system to obtain the invention as specified in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792