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 .
Response to Arguments
Applicant's arguments filed 11 August 2026 have been fully considered but they are not persuasive with respect to the written description rejection under 35 U.S.C. 112(a). As discussed below, the disclosure and newly added amendments do not have sufficient support in the written description. This compounded by the fact that the amendments introduce indefiniteness issues under 112(b). Namely, it is not clear what constitutes an optical dose and how this optical dose is adjusted based on the measured parameters.
Applicant’s arguments, see remarks, filed 11 August 2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered and are persuasive. The rejections have been withdrawn.
Claim Objections
Claim 13 and dependents thereof are objected to because of the following informalities: claim 13 recites “a optical dose” in line 17 rather than “an optical dose.” Appropriate correction is required.
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 1-2,4-14,16-19 and 21-23 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 claims require using a controller to receive respiratory information, blood test results, and body temperature to control various properties of emitted electromagnetic radiation which lacks sufficient support in the original disclosure. The disclosure indicates the controller is used to determine and control the properties of electromagnetic radiation to treat acute respiratory distress (ARDS). The properties are determined based on changes in respiration rate, blood oxygen level, and body temperature. However, the disclosure indicates changing the electromagnetic radiation parameters based only on general trends in the data without indicating how the electromagnet radiation parameters are specifically determined. For example, the specification recites:
“In one embodiment, the size of the change (i.e., the amount of the change) in the property 30 may be determined by the processor circuitry 22. That is, if a positive trend is found in the respiratory information 28, the processor circuitry 22 may cause a decrease in the property 30 of the light 16. The size of this decrease (i.e., the amount of the decrease in the property 30 of the light 16 being emitted) may be based on an amount of the positive change in the respiratory information 28 over the duration of time 32.”
The specification contains many similar recitations but does not describe an algorithm correlating changes in respiration rate, blood oxygen saturation and body temperature to changes in optical dose, optical intensity, time duration of emission, fluence, wavelength or optical power. For example, if the blood oxygen saturation drops by 5% how is a change in wavelength determined and what is the value of this wavelength? Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed [MPEP § 2161.01].
Newly added claim 22 introduces a “weighted merit function based on biomarkers.” The specification indicates the weighted merit function is applied without describing an algorithm or steps for applying the function. Namely, the specification states: “The trace called "Respiratory Health Signal" represents a merit function used to represent the patient's immediate health state. For example, the merit function may be a weighted mix of respiratory parameters, blood test results, heart rate, etc.” There is no description identifying how the parameters are weight with respect to one another or how the merit function is applied to adjust the optical dose. The weighted merit function is not adequately described by the specification.
Newly added claim 23 introduces a “fit applied to the respiratory information.” The specification merely indicates the fit is applied without describing an algorithm or steps for applying the fit. Namely, the specification states: “For example, a fit (e.g., linear, quadratic, exponential etc.) may be applied to the respiratory information 28 and/or the property 30 and a term (also referred to as a coefficient) of the fit (e.g., slope) may be used as a measurement of the amount of change.” Different types of curve fits are lists but there is no direction on how term is applied to adjust the optical dose. The fit is not adequately described by the specification.
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 1-2,4-14,16-19 and 21-23 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 "the period of time" in lines 34, 39 and 59. There is insufficient antecedent basis for this limitation in the claim. It appears “the period of time” should be the previously recited “duration of time.”
Regarding claims 1, 13 and 18, the metes and bounds of the claim limitation “wherein the optical dose of the electromagnetic radiation comprises at least one of optical dose, optical intensity, time duration of emission, fluence, wavelength, or optical power” cannot be determined by the examiner. The limitation self-defines an optical dose as an optical dose along with a list of other optical properties. A wavelength is an optical property not an optical dose additionally making the limitation unclear.
All remaining claims are rejected for depending from an indefinite claim.
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 NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 8 October 2026
