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 April 29, 2026 have been fully considered but they are not persuasive. The Examiner notes that this Office Action is in response to Applicant’s Appeal Brief filed on April 29, 2026. The Examiner has reopened prosecution to introduce evidence showing that heating elements disposed within or on an airway to prevent condensation is well-understood, routine, and conventional activity that is known in the art. The Examiner maintains that the claims are directed to ineligible subject matter as detailed below.
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. These judicial exceptions are 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). The Examiner also points to references to Shaw et al.,(US 2007/0016092), Meka et al., (US 2007/0173731), and Babb et al., (US 4,671,298), all of which teach devices for breath analysis wherein the device comprises a heating element along an airway (Shaw et al., paragraph 0047, Meka et al., paragraph 0053, Babb et al., column 8 lines 16-26 and column 15 lines 19-23). Reference to Shaw et al., teach utilizing a heating element to regulate temperature increases accuracy and precision of the measurements, whereas references to Meka et al., and Babb et al., teach utilizing a heating element to prevent condensation within an airway. 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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
Prosecution Insights