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 Amendment
This office action is responsive to the amendment filed on October 21, 2025. As directed by the amendment: no claim(s) have been amended, claim(s) 3, 5-7, 10-13, 16-17, 21-24, 27-29, 31, 37-42, and 45-51 have been cancelled, and no claim(s) have been added. Thus, claims 1-2, 4, 8-9, 14-15, 18-20, 25-26, 30, 32-26, 43-44, and 52-58 are currently pending in the application.
Response to Arguments
Applicant's arguments filed October 21, 2025 have been fully considered but they are not persuasive. The applicant first argues that the Office Action alleges the abstract idea is “a machine.” It is clear that this added wording “without significantly more” should not be there and this is referring to Step 1 as bolded within the analysis which deems whether or not the claim is directed to a process, machine, manufacture or composition of matter. The examiner explicitly details in the Step 2A:Prong 1 analysis that this is directed to a mental process. The applicant principally argues that this is not a mental process and cannot be done using pen/paper because It utilizes an optical spectroscopy probe fixable to the user’s skin. The examiner respectfully disagrees. More specifically, the additional elements of an optical spectroscopy probe (which comprises a NIRS probe), digital user interface, and digital data processor are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f).
Lastly, the applicant argues that the judicial exception is integrated into a practical application. The examiner respectfully disagrees. Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., a digital data processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
The examiner is not convinced and the rejection of the claims under 35 U.S.C. 101 is maintained.
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 1-2, 4, 8-9, 14-15, 52-53 and 58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a machine (Step 1). The claim(s) recite(s) acquiring blood oxygenation data representative of deoxyhemoglobin levels over time, storing preset deoxyhemoglobin level variations corresponding to benchmark preset blood oxygenation profiles, defining at least a lower and higher health risk rating of hyperoxia, monitoring relative variations in said deoxyhemoglobin levels, evaluating the relative variations against the stored preset profiles, and outputting a signal in response to said evaluation for display .
Furthermore, the claimed invention is directed to an abstract idea, specifically to a mental process (Step 2A:Prong 1), without significantly more. The claim(s) recite steps that are merely data gathering and data analysis/evaluation that can be done (using pen/paper) to evaluate hyperoxia of a user. This is merely nothing more than what a doctor or user would do when analyzing an oxygenated state of a user using generic data gathering tools such as sensors or mathematical tools for calculations.
With regard to Step 2A, Prong 2, this judicial exception is not integrated into a practical application because it is merely directed to the judicial exception of a mental process that is used to determine the hyperoxia state of a user. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it merely requires data from a sensor (optical spectroscopy probe) that is a generic sensor that are used to monitor the oxygenated levels of a user. Essentially, it is well-understood, and known in the art to collect physiological data and then analyze such data in order to determine a mental state. (Simply appending well-understood, routing conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception—See MPEP 2106.05(d) and Berkheimer).
The claims further recite a processor to perform the steps of analyzing the physiological data to determine the oxygenation/hyperoxia of the user which amounts to no more than mere instructions to apply the exception using a generic computer component, which cannot provide an inventive concept. Additionally, well-known, routing and convention activity is not enough to add significantly more than the abstract idea itself. Per the Berkheimer requirement, a processor analyzing optical spectroscopy data in order to determine oxygenation levels: Shuler (WO 2010/0129528 A1) (as listed on IDS submitted on 10/9/21)(e.g. pg. 25 lines 28-31, pg. 32 lines 26-30 and pg. 38 lines 1-3).
Therefore, the claims considered in combination as a whole are not patent eligible.
Conclusion
THIS ACTION IS MADE FINAL. 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 JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough February 1, 2025
/J.F.H./Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796