DETAILED ACTION
Claims 1-9 are hereby under examination.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/10/2026 is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a device comprising a flow control circuit” (claim 4 and claim 5) and “a device comprising a circuit and a mass flow controller” (claims 6-9) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, line 4 recites “the breath”, however it appears it should read --the exhaled breath-- (emphasis added) to maintain consistent claim language.
Regarding claim 1, lines 15-16 recite “the subject’s sepsis score, wherein if the sepsis score”, however it appears it should read --the subject’s sepsis risk score, wherein if the sepsis risk score-- (emphasis added) to maintain consistent claim language.
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 8 and 9 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.
Regarding claim 8, the claim recites “the measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller”. However, claim 4 recites “the measuring nitric oxide is performed with a device comprising a flow control circuit”. In light of the specification, it is currently unclear the relationship between the recited devices and circuits. The only recitations regarding circuitry in relation to a device to measure nitric oxide appears in para. [0034] and para. [0053], but the specification does not make it clear if the recited devices and circuits are the same, related, or different. For the purposes of examination, “a device comprising a circuit and a mass flow controller” is being interpreted as being the same as/related to “a device comprising a flow control circuit”. It is recommended to the Applicant to amend the claims to either clearly link or clearly differentiate the claimed elements.
Regarding claim 9, the claim recites “the measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller”. However, claim 5 recites “the measuring nitric oxide is performed with a device comprising a flow control circuit”. In light of the specification, it is currently unclear the relationship between the recited devices and circuits. The only recitations regarding circuitry in relation to a device to measure nitric oxide appears in para. [0034] and para. [0053], but the specification does not make it clear if the recited devices and circuits are the same, related, or different. For the purposes of examination, “a device comprising a circuit and a mass flow controller” is being interpreted as being the same as/related to “a device comprising a flow control circuit”. It is recommended to the Applicant to amend the claims to either clearly link or clearly differentiate the claimed elements.
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 1-9 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.
Analysis of independent claim 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claim recites the following:
Assigning one point for each determined value if: the measured nitric oxide concentration is below 8 parts per billion (ppb) or above 12 ppb, the body temperature is below 36 degrees Celsius or above 38 degrees Celsius, the heart rate is greater than 90 beats per minute, or the respiratory rate is greater than 20 breaths per minute; and
Summing the assigned points to determine the subject's sepsis score.
These elements required of claim 1 are drawn to an abstract idea since (1) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper; and/or (2) they involve methods of organizing human activity such as managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Assigning a point for each determined value is a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can view nitric oxide concentration, body temperature, heart rate, and/or respiratory rate data of a subject on a piece of paper, and mentally assign a point to each category if the data is above and/or below certain thresholds. There is nothing to suggest an undue level of complexity in the assigning a point step. Alternatively and/or additionally, assigning a point is drawn to managing personal behavior or relationships or interactions between people, specifically, following rules or instructions. The identified abstract ideas above are drawn to following rules or instructions for determining sepsis risk.
Summing the assigned points to determine the subject’s sepsis risk is a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can mentally sum the mentally determined points to determine a sepsis risk score. There is nothing to suggest an undue level of complexity in the summing step. Alternatively and/or additionally, summing the assigned points is drawn to managing personal behavior or relationships or interactions between people, specifically following rules or instructions for determining sepsis risk.
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., N/A), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “analyzing an exhaled breath”, “measuring nitric oxide in the breath to determine a measured nitric oxide concentration of the breath”, and “obtaining at least one vital characteristic of the subject selected from: …” - with no structure recited); the post-solution activity of: (e.g. “if the sepsis risk is greater than or equal to 2 the subject is prescribed systemic antibiotics”); using generic data-outputting components (e.g. N/A)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for active treatment. See MPEP 2106.04(d)(2) regarding positive limitations regarding a prescribed medication being actually used by the patient. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, “analyzing an exhaled breath … measuring nitric oxide in the breath …” is well-understood, routine, and conventional, as disclosed by Anderson et al. (US 20190317074 A1) - para. [0031], para. [0037].
For example, “obtaining at least one vital characteristic value …” is well-understood, routine, and conventional, as disclosed by Anderson et al. (US 20190317074 A1) - para. [0048].
For example, “the subject is prescribed system antibiotics” is well-understood, routine, and conventional, as disclosed by Anderson et al. (US 20190317074 A1) - para. [0043], para. [0044].
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps of necessary data gathering, and/or intended use and/or field of use limitations, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Analysis of the dependent claims:
Claims 2-9 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“employing a correction factor to adjust the nitric oxide concentration to a standard flow rate” (claim 2), “wherein the employing includes multiplying the measured nitric oxide concentration and a correction factor, wherein the correction factor is: 20/(208.6795 *FR-0.5995), wherein FR is the measured flow rate of the exhaled breath” (claim 3)),
Further describe the pre-solution activity (or the structure used for such activity) (“measuring a flow rate (FR) for the exhaled breath” (claim 2), “measuring nitric oxide is performed with a device comprising a flow control circuit” (claim 4), “measuring nitric oxide is performed with a device comprising a flow control circuit” (claim 5), “measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller” (claim 6), “measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller” (claim 7), “measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller” (claim 8), “measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller” (claim 9)),
Further describe the computer implementation (N/A), and
Further describe the post-solution activity (N/A) (recited at a high level of generality).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a device comprising a flow control circuit” and “a device comprising a circuit and a mass flow controller” is well-understood, routine, and conventional, as disclosed by the instant specification - para. [0034] and Anderson et al. (US 20190317074 A1) - Fig. 1, para. [0030].
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for active treatment. See MPEP 2106.04(d)(2) regarding positive limitations regarding a prescribed medication being actually used by the patient. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-9 are rejected.
Claim Rejections - 35 USC § 103
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 20190317074 A1), hereinafter referred to as Anderson, in view of Mark et al. (US 20090149724 A1), hereinafter referred to as Mark.
The claims are generally directed towards a method for non-invasively determining a sepsis risk score in a human subject comprising: analyzing an exhaled breath; measuring nitric oxide in the breath to determine a measured nitric oxide concentration of the breath; obtaining at least one vital characteristic value of the subject selected from: a body temperature, a heart rate, or a respiratory rate; assigning one point for each determined value if: the measured nitric oxide concentration is below 8 parts per billion (ppb) or above 12 ppb, the body temperature is below 36 degrees Celsius or above 38 degrees Celsius ,the heart rate is greater than 90 beats per minute, or the respiratory rate is greater than 20 breaths per minute, and summing the assigned points to determine the subject's sepsis score, wherein if the sepsis score is greater than or equal to 2 the subject is prescribed systemic antibiotics.
Regarding claim 1, Anderson discloses a method for non-invasively determining a sepsis risk score in a human subject (Abstract, Fig. 1, Fig. 2, para. [0018]) comprising:
analyzing an exhaled breath (Fig. 2, para. [0030], “collect the exhaled breath … CO2 detector … NO detector …”, para. [0031], “exhaled breath sample is collected from a patient …”);
measuring nitric oxide in the breath to determine a measured nitric oxide concentration of the breath (Fig. 2, para. [0037], “NO concentration in the treated exhaled breath is determined …”);
obtaining at least one vital characteristic value of the subject selected from (para. [0048], “other non-invasive measurements could be incorporated as well … pulse oximetry result, a respiratory rate, a blood pressure reading, a patient temperature reading, or a cognitive assessment reading …”):
a body temperature (para. [0048], “a patient temperature reading”),
a heart rate (para. [0048], “pulse oximetry result”), or
a respiratory rate (para. [0048], “a respiratory rate”);
assigning one point for each determined value if:
the measured nitric oxide concentration is below 8 parts per billion (ppb) or above 12 ppb (para. [0041], para. [0043]),
summing the assigned points to determine the subject's sepsis score, wherein if the sepsis score is greater than a threshold the subject is prescribed systemic antibiotics (para. [0042-0043], “individual test results can be correlated to a sepsis diagnosis … treating the patient with one or more antibiotics … sepsis risk score is high … develop a more aggressive treatment plan … intravenous delivery of antibiotics … high dose antibiotics, broad spectrum antibiotics …”, para. [0047-0048]).
However, Anderson does not explicitly disclose assigning one point for each determined value if: the body temperature is below 36 degrees Celsius or above 38 degrees Celsius, the heart rate is greater than 90 beats per minute, or the respiratory rate is greater than 20 breaths per minute, and summing the assigned points to determine the subject’s sepsis score, and prescribing systemic antibiotics if the score is greater than or equal to 2.
Mark teaches of an analogous method of non-invasively determine a sepsis risk score in a human subject (Abstract, Fig. 1). Mark further teaches assigning one point for each determined value if: the body temperature is below 36 degrees Celsius or above 38 degrees Celsius, the heart rate is greater than 90 beats per minute, or the respiratory rate is greater than 20 breaths per minute, and summing the assigned points to determine the subject’s sepsis score (Fig. 1, para. [0003]). Mark further teaches prescribing systemic antibiotics if the score is greater than or equal to 2 (Fig. 1, para. [0004]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify method disclosed by Anderson to additionally assign one point for each determined value if: the body temperature is below 36 degrees Celsius or above 38 degrees Celsius, the heart rate is greater than 90 beats per minute, or the respiratory rate is greater than 20 breaths per minute, and summing the assigned points to determine the subject’s sepsis score, and prescribing systemic antibiotics if the score is greater than or equal to 2, as taught by Mark. This is because Mark teaches point value sepsis determination, and the specific thresholds are a known medical standard for identifying a risk of sepsis, and would improve the method of Anderson by providing a more comprehensive risk score (para. [0003-0004]).
Claims 2, 4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 20190317074 A1), hereinafter referred to as Anderson, in view of Mark et al. (US 20090149724 A1), hereinafter referred to as Mark as applied to claim 1 above, and further in view of Eugene Gerety (US 20200018735 A1), hereinafter referred to as Gerety.
Regarding claim 2, modified Anderson discloses the method of claim 1.
However, modified Anderson does not explicitly disclose wherein the measured nitric oxide concentration is calculated by: measuring a flow rate (FR) for the exhaled breath; employing a correction factor to adjust the nitric oxide concentration to a standard flow rate.
Gerety teaches an analogous method monitoring a concentration of substances from an exhaled breath (Abstract). Gerety further teaches measuring a flow rate (FR) for the exhaled breath; and employing a correction factor to adjust the concentration to a standard flow rate. (para. [0026], “conversion to other target gas signal … calibration may take into account other factors such as flow rate … suitably programmed as a look-up table, mathematical equation …”, para. [0029], para. [0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Anderson to additionally measure a flow rate for the exhaled breath, and employ a correction factor to adjust the nitric oxide concentration to a standard flow rate, as taught by Gerety. This is because Gerety teaches flow rates and flow regulators can cause changes in concentrations, and measuring a flow rate and employing a correction factor allows for accurate concentrations to be determined (para. [0026]).
Regarding claim 4, modified Anderson discloses the method of claim 2, where the measuring nitric oxide is performed with a device comprising a flow control circuit (Fig. 1, element 100, para. [0024-0030], “sepsis assessment device … one or more device processing elements … flow regulator …”).
Regarding claim 6, modified Anderson discloses the method of claim 2, where the measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller (Fig. 1, element 100, para. [0024-0030], “sepsis assessment device … one or more device processing elements … flow regulator …”).
Regarding claim 8, modified Anderson discloses the method of claim 4, where the measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller (Fig. 1, element 100, para. [0024-0030], “sepsis assessment device … one or more device processing elements … flow regulator …”).
Claims 3, 5, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 20190317074 A1), hereinafter referred to as Anderson, in view of Mark et al. (US 20090149724 A1), hereinafter referred to as Mark, in view of Eugene Gerety (US 20200018735 A1), hereinafter referred to as Gerety as applied to claim 2 above, and further in view of Silkoff et al. (“Marked Flow-dependence of Exhaled Nitric Oxide Using a New Technique to Exclude Nasal Nitric Oxide”) (cited in the IDS filed 04/10/2026), hereinafter referred to as Silkoff.
Regarding claim 3, modified Anderson discloses the method of claim 2.
However, modified Anderson does not explicitly disclose wherein the employing includes multiplying the measured nitric oxide concentration and a correction factor, wherein the correction factor is: 20/(208.6795 *FR-0.5995), wherein FR is the measured flow rate of the exhaled breath.
Silkoff teaches an analogous method for measuring nitric oxide in the breath to determine a measured nitric oxide concentration of the breath (Abstract). Silkoff further multiplying the measured nitric oxide concentration and a correction factor, wherein the correction factor is: 20/(208.6795 *FR-0.5995), wherein FR is the measured flow rate of the exhaled breath (Abstract, Discussion, “relationship of NOplat to expiratory flow was well described by the equation derived from the regression: NOplat = 208.6795 X(flow rate)-0.5995 … NOplat levels measured with expiratory pressure of 20 mmHg …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the correction taught by modified Anderson to explicitly include multiplying the measured nitric oxide concentration and a correction factor, wherein the correction factor is: 20/(208.6795 *FR-0.5995), wherein FR is the measured flow rate of the exhaled breath, as taught by Silkoff. This is because Silkoff teaches amplifying low flow rate NO concentration signals allows for more accurate NO concentrations (Abstract).
Regarding claim 5, modified Anderson discloses the method of claim 3, where the measuring nitric oxide is performed with a device comprising a flow control circuit (Fig. 1, element 100, para. [0024-0030], “sepsis assessment device … one or more device processing elements … flow regulator …”).
Regarding claim 7, modified Anderson discloses the method of claim 3, where the measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller (Fig. 1, element 100, para. [0024-0030], “sepsis assessment device … one or more device processing elements … flow regulator …”).
Regarding claim 9, modified Anderson discloses the method of claim 5, where the measuring nitric oxide is performed with a device comprising a circuit and a mass flow controller (Fig. 1, element 100, para. [0024-0030], “sepsis assessment device … one or more device processing elements … flow regulator …”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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