DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed December 15, 2025 have been fully considered but they are not persuasive. At the outset, the Examiner notes that the amendments to the instant claim have overcome the rejections under 35 U.S.C. 112(b) detailed in the previous Office Action. Applicant has argued that the instant claims are not directed to a law of nature and an abstract idea, and are therefore directed to eligible subject matter. The Examiner respectfully disagrees.
With respect to the law of nature, the Examiner contends that the amount of carbon dioxide and unconsumed oxygen in a volume of exhaled air results from a subject’s disease state, thus the measured carbon dioxide and unconsumed oxygen is a law of nature.
With respect to the abstract idea, the Examiner notes that the steps of calculating, comparing, and applying with a controller are abstract ideas, and not the steps of measuring gas concentrations as argued by Applicant. The steps of calculating, comparing, and applying are mental steps in that they only require analyzing collected data, and making a determination of whether a subject has a pulmonary embolism or not. Also, as set forth in the MPEP, a claim that requires a computer (controller) may recite a mental process provided that the mental process is performed on a generic computer, or the computer is merely a tool to perform a mental process (MPEP 2106.04(a)(2) III C). The claimed controller that performs the calculating, comparing, and applying steps represents a generic computer that is presented at a high level of generality. As such, the Examiner maintains that the claims are directed to an abstract idea. The Examiner also contends that the claims do not recite a practical application as nothing occurs after the presence or absence of pulmonary embolism is determined. Also, the Examiner maintains that the additional limitations recited in the claim are directed to well-understood, routine, and conventional activity as evidenced by reference to Kline who teaches measuring carbon dioxide and oxygen in expired air, calculating a carbox ratio, and diagnosing pulmonary embolism based on the measured data. Additionally, the Examiner points out that reference to Kline teaches a device having a mouthpiece, breathing tube, and a plurality of sensors, thus none of the additional limitations amounts to significantly more. As such, the Examiner contends that the limitations of the instant claims recite a judicial exception without significantly more, and therefore are directed to ineligible subject matter under 35 U.S.C. 101.
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, 3-8, 10-12, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) a law of nature and an abstract idea. This judicial exception is not integrated into a practical application because the claims recite a mental process in which one gathers data from a subject, performs a series of calculations, and compares the results to a threshold value to determine presence or absence of a pulmonary embolism. Independent claim 1 recites a method for identifying the presence of a respiratory dysfunction comprising, providing a handheld unit defining an airway, a plurality of sensors in the airway, a heating element, a mouthpiece, and a controller wherein the handheld unit measures a concentration of produced carbon dioxide in a volume of exhaled air, a concentration of unconsumed oxygen in a volume of exhaled air, calculates a carbox ratio which represents the concentration of produced carbon dioxide in relation to the concentration of unconsumed oxygen, compares the carbox ratio to first and second known values indicating the presence and absence of a respiratory dysfunction, applies one or more normalization factors to the carbox ratio, and determines a presence or absence of a respiratory dysfunction by comparing a normalized carbox ratio to a threshold value to determine the presence or absence of pulmonary embolism. The amount of produced carbon dioxide and unconsumed oxygen in the volume of exhaled air results from the subjects disease state, thus the measured carbon dioxide and unconsumed oxygen is a law of nature. The steps of calculating a carbox ratio, comparing the carbox ratio to first and second known values, applying normalization factors to the carbox ratio, and determining a presence or absence of a pulmonary embolism are mental steps that requires nothing more than analyzing data to determine if a subject has a pulmonary embolism (MPEP 2106.04(a)(2) III). Independent claim 1 recites a controller that performs the calculating, comparing, applying, and determining steps; however, the limitations are still mental processes as performing a mental process on a generic computer, or using a computer as a tool to perform a mental process still recites an abstract idea (MPEP 2106.04(a)(2)III C). The Examiner also contends that the claims are directed to mere data gathering as they recite performing clinical tests to obtain formation at a high level of generality. As such, the Examiner views the calculating, comparing, applying, and determining steps of claim 1 as mental processes that only requires analysis of the data generated by the clinical tests performed on a subject, thus the claim also recites an abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional claim limitations are directed to well understood, routine activity. In support of this view, the Examiner points to reference to Kline (US 2007/0078357) which teaches measuring concentration of carbon dioxide and oxygen in expired air (paragraphs 0034, 0036), and calculating a carbox ratio (Abstract, paragraphs 0021, 0041) in a process for diagnosing pulmonary embolism. Reference to Kline also teaches a system comprising a mouthpiece (paragraph 0035, figure 4 #32), a breathing tube (airway, paragraph 0035, figure 4 #34), and three sensors positioned in the airway (paragraph 0035, figure 4 #'s 36, 38, 40). Given these teachings, the Examiner contends that the additional limitations are directed to well understood, routine, and conventional activity known in the art. As such, the Examiner contends that the additional elements of independent claim 1 do not amount to significantly more than the judicial exception. Therefore, when taken as a whole, the instant claims are directed to ineligible subject matter under 35 U.S.C. 101 as the claims recite a law of nature and an abstract idea without adding significantly more. For the sake of brevity, the Examiner has limited the discussion to independent claim 1, but notes that the rationale also holds true for claims 3-8, 10-12, and 15.
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 DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797
/BRIAN R GORDON/Primary Examiner, Art Unit 1798