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 .
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 1-20 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 limitation “fluid input” in independent claims, as amended, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no structure of the fluid input, as best understood by the specification, the mouth piece and connector 103 are different than the fluid input (¶[0046]). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims not listed are rejected by virtue of claim dependency.
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.
Claims 1, 5, 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy (US 20200337594 A1- previously cited) in view of Liu et al. (US 20170184564 A1- previously cited), hereinafter Liu, and Acker et al. (US 20150032019- previously cited), hereinafter Acker.
Regarding claims 1 and 11, Reddy teaches a method comprising a device that includes: a fluid input configured to be in fluid communication with a respiratory tract of a patient, wherein the fluid input receives an exhaled breath sample from the patient (see ABSTRACT and ¶[0035,0198]);
a flow regulator that controls a rate of exhalation of the exhaled breath sample from the patient (¶[0044], “a housing, such as 104, can include a flow regulator operable to admit a sufficient sample volume of exhaled breath into the housing”);
a nitric oxide (NO) measurement device that determines a NO concentration in the exhaled breath sample (¶[0031,0024], nitric oxide concentration is detected);
an input/output interface; a processing element in electrical communication with the NO measurement device and the input/output interface (¶[0081-82], input/output interface 130 and processing module 140), wherein the processing element: receives a first signal corresponding to the NO concentration ( ¶[0005, 0193,0199]).
Reddy fails to teach determining a sepsis risk score based on the first signal; and transmits the sepsis risk score to the input/output interface.
It is noted, Reddy acknowledges that a plurality of chemicals and gases can be used as biomarkers to detect sepsis (see para. [0190-191]). Additionally, the NO is detected at a part per billion level (see para. [0065,0203], “In this manner, an example sensor module with a MXene in a 3D-M framework can perform at room temperature, can display a relatively high sensitivity to extremely low concentrations (ranging from several parts per million (PPM) to several parts per billion (PPB) levels) of certain substances” and “detecting the biomarkers VOCs that are present at part per billion (ppb) level in human breath” thereby establishing the measurement method).
Liu teaches a sensor for nitric oxide detection that can be used detect infections, including sepsis (see ABSTRACT and para. [0034]). Liu also acknowledges that nitric oxide production is significantly higher in sepsis, and that nitic oxide samples in breath provide a non-invasive detection of the onset of sepsis in a subject. Furthermore, Liu states “where the sample is a bodily sample obtained from a subject that has or is suspected of having a condition, pathology, or disorder associated with aberrant nitric oxide levels, once the current level generated by the bodily sample tested with the sensor is determined, the level can be compared to a predetermined value or control value to provide information for diagnosing or monitoring of the condition, pathology, or disorder in a subject” (emphasis added) indicating that in order to establish a sepsis condition or suspicion/likelihood of a sepsis condition the measured level of NO per ppb will be compared to a predetermined or control value, e.g., 10, 13, 20, 200 ppb, etc., and “In order to carry out the detection of NO in ppb (parts per billion) range, a different experimental arrangement is needed. NO gas of 250 ppb level is used. The NO gas is then mixed with air further diluting the NO concentration in 4-25 ppb range” indicating the range of concentrations per ppb that the sensor is able to detect and therefore relevant to the measurements obtained from the subject (see para. [0048,0061]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Reddy, such that sepsis risk score is correlated to the NO concentration, as taught by Liu, to aid in providing a non-invasive detection of sepsis in a subject. Also, the modification would merely be combining prior art elements (sepsis determination) according to known methods (NO concentration correlated to sepsis) to yield predictable results.
As such, Reddy-Liu teach wherein the sepsis risk score is transmitted to the I/O interface (¶[0091] of Reddy, “a result from the biomarker processing module 122 can be output to a display”); and treating the patient based on the transmitted sepsis risk score (¶[0100-01], “receive processed data from the biomarker processing module 122, and can be further operable to determine, based at least in part on the processed data from the biomarker processing module 122, one or more diagnoses and/or treatments for a subject”).
Reddy-Liu fail to teach determining end tidal NO concentration in the exhalated breath sample and that the first signal corresponds to end tidal NO concentration, and determining sepsis based on the end tidal NO concentration.
Acker teaches determining end tidal NO concentration in the exhalated breath sample and treating the patient based on the disease (¶[0010,0089-91], “end-tidal gas monitoring apparatus . . . . the gas sensor is, . . . nitric oxide”). Acker’s invention is not related to a particular disease, rather known diseases associated with the specific gases monitored are known in the art to be related.
Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of the method of Reddy-Liu, such that it measures end tidal nitric oxide in exhaled breath sample and uses it to determine a condition, as taught by Acker, to aid in preventing or inhibiting the condition or relieving the patient from the symptoms of the condition (¶[0091] of Acker).
Reddy-Liu-Acker correspondingly arrive to the claimed invention of an end tidal nitric oxide device and treating a patient with sepsis.
Regarding claims 5 and 16, Reddy teaches wherein the fluid input receives a second exhaled breath sample at a time after receiving the exhaled breath sample; and determines, via the processing element, a second NO concentration in the second exhaled breath sample; determines, via the processing element, a second sepsis risk score correlated to the second NO concentration (¶[0037,0049, 0080,0092] of Reddy, “processing to compare and/or match against signals and/or signal patterns associated with substances previously detected” therefore indicating multiple signals are collected and analyzed).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Reddy in view of Liu and Acker, as applied to claim 1, and further in view of Carnahan (US 20170122931).
Regarding claim 2, Reddy-Liu-Acker fails to teach wherein the flow regulator is a mass flow regulator.
Carnahan teaches an analyte measuring device, where the analyte is nitric oxide, and comprises a mass flow regulator/controller (abstract, ¶[0105,0110], and fig. 7).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Reddy-Liu-Acker, such that the flow regulator is a mass flow regulator, as taught by Carnahan, to aid in monitoring analytes in gasses.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Reddy in view of Liu and Acker, as applied to claim 11, and further in view of Guy (BE 1020244- previously cited).
Regarding claim 13, Reddy-Liu-Acker fail to teach wherein the exhaled breath is collected at the controlled rate of exhalation is between and including 20 mL/sec and 50 mL/sec.
Guy teaches a device and method for monitoring exhaled breath samples of NO wherein the exhaled breath sample is collected at a rate of 50 cm3/s [50ml/s] (¶[0025,0030-32]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Reddy-Liu-Acker, such that the breath sample is collected a controlled rate of exhalation, as taught by Guy, to aid in reducing inaccuracies due to variations of airflow on the detector (¶[0032]).
Claims 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy in view of Liu and Acker, as applied to claim 11, further in view of Langley et al. (US 20150024969 A1- previously cited) referred to as Langley hereinafter.
Regarding claims 3 and 14, Reddy teaches wherein the method further comprises determining additional measurements of a vital statistic of the patient selected from a group consisting of pulse rate, blood pressure, and oxygen (see para. [0098-99]). Reddy-Liu-Acker fail to teach wherein determining the sepsis risk score is further based on additional measurements recorded, including respiratory rate, heart/pulse rate, and body temperature.
Langley teaches a method for determining a sepsis infection (see ABSTRACT) based on body temperature, blood pressure, respiratory rate, heart rate (¶[0018] and table 5, a plurality of physiological parameters are used in making the determination). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Reddy-Liu-Acker, such that the sepsis risk score is also dependent on respiratory rate, heart/pulse rate, and body temperature, as taught by Langley, to aid in reliably determining the severity of the disease (see para. [0018,0024,0058]).
Claims 15 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy in view of Liu, Acker, and Langley, as applied to claim 14, further in view of Anderson et al. (WO 03084388- previously cited), referred to as Anderson hereinafter.
Regarding claims 15, Langley teaches wherein the vital statistic is a body temperature of the patient (see para. [0018]). Reddy-Liu-Langley fail to teach wherein a body temperature below about 96.8°F or above about 100.4°F is indicative of an elevated risk of sepsis.
Anderson teaches a method for detecting sepsis wherein body temperature of below about 96.8°F (36°C) or above about 100.4°F (38°C) is indicative of sepsis (see page 2 [paragraph 4]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Reddy-Liu-Acker-Langley, such that a specific body temperature range is established, as taught by Anderson, to aid in identifying and determining sepsis.
Claims 6-9 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy in view of Liu and Acker, as applied to claim 16, further in view of Shah et al. (US 20170325749 A1- previously cited), referred to as Shah hereinafter.
Regarding claims 6 and 17, Reddy-Liu-Acker fail to teach determining a changed sepsis risk score based on a difference between the sepsis risk score and the second sepsis risk score; and determines an improvement or a worsening of a systemic sepsis condition in the patient based on the changed sepsis risk score.
Shah teaches a method for detection of sepsis in a user, wherein the method includes determining rate of change (difference) between a primary input and a secondary input to further determine the development(improvement and/or worsening) of sepsis. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Reddy-Liu-Acker, such that a difference between sepsis risk score were determined, as taught by Shah, to aid in refining the determination of the sepsis risk score (see para. [0031]).
Regarding claims 7 and 18, Reddy-Liu-Acker fail to teach determining a changed NO concentration by subtracting the second NO concentration from the NO concentration.
Shah teaches a method for detection of sepsis in a user, wherein the method includes determining rate of change (subtracting) between a primary input and a secondary input to further determine the development(improvement and/or worsening) of sepsis. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Reddy-Liu-Acker, such that a difference between sepsis risk score were determined, as taught by Shah, to aid in refining the determination of the sepsis risk score (see para. [0031]).
Regarding claims 8-9, 19 and 20, sections of Reddy-Liu-Acker-Shah, cited above teach that an improvement in systemic sepsis condition can be correlated to a negative and/or positive value resulting from subtracting the second NO concentration from the NO concentration (see para. [0031,0072] of Shah, one skilled in the art understands that determining a rate of change result in a negative value or positive value).
Examiner’s Note
The art of record fails to teach or suggest, in combination with the base claim, the particular end tidal NO concentration threshold and specific unit of measurement (ppb). Adding the threshold and unit of measurement in the independent claims may overcome the rejection above.
Response to Arguments
Arguments in the reply filed 06/11/2026 are persuasive. However, amendments require new rejections that rely on prior not used before in the rejection. The claims as written are broad, as such, prior art viewed in the broadest reasonable interpretation overcome the limitations. As discussed above, adding the step comparing a risk score to a threshold and the particular unit of measurement related to the threshold(s) can overcome the rejection.
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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