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 .
Election/Restrictions
Applicant’s election of invention I in the reply filed on 7/23/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/23/25.
Claims 1-4 and 9 are examined on the merits. Claim 9 is newly presented.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/27/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
(Prior Objection Withdrawn due to amendments in claim 2)
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(Prior Rejection Withdrawn due to amendments) Claim(s) 1 is rejected under 35 U.S.C. 102a1 as being anticipated by Davis et al. (US PGPub 2005/0085740).
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.
(New Rejections Necessitated by Amendment) Claims 1-4 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.
Claim 1 recites, “…retains volatile organic compounds (VOCs) for analysis while excluding water and other light-weight gases…”. However, the claims nor the specification define what “light-weight gases” are. What is the gas compared to to determine it is light-weight and what are the metes and bounds of “light-weight gases”. Claims 2-4 and 9 are also rejected because they depend from claim 1, but do not remedy this deficiency.
Claim 1 recites, “…concentrates vapors and entraps fine airborne particles…”. However, the claims nor the specification define what “fine airborne particles” are. What size or shape do the particles need to be to meet the claimed requirement of “fine”. Furthermore, what are the metes and bounds of “fine airborne particles”. Claims 2-4 and 9 are also rejected because they depend from claim 1, but do not remedy this deficiency.
Claim 1 recites, “…while kept cool…”. However, the claims nor the specification define what temperature “cool” includes or excludes. Furthermore, what are the metes and bounds of “cool” with regard to receiving the cleaned sample. Claims 2-4 and 9 are also rejected because they depend from claim 1, but do not remedy this deficiency.
Claim 1 recites the limitation "IMS" in line 37. There is insufficient antecedent basis for this limitation in the claim.
Claims 1 and 4 recite, “strongly indicative of COVID-19 infection” and “strongly indicative VOCs”. However, the claims nor the specification establish what the metes and bounds of strongly indicative are relative to COVID-19 infection and VOCs. Therefore, it is unclear how one of ordinary skill in the art would interpret this limitation. Claims 2-4 and 9 are also rejected because they depend from claim 1, but do not remedy this deficiency.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “a protonated molecular ion”, and the claim also recites “(MH+)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “a dimer ion”, and the claim also recites “(M2H+)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
(Prior Rejection Maintained and Extended to New Claim) Claims 1-4 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to law of nature (judicial exception) without significantly more. The claim(s) recite(s) monitoring volatile organic compound detection in a subject when the subject is suspected of being infected with COVID-19.
This judicial exception is not integrated into a practical application because claimed method detects the release of volatile organic compounds into the breath of a subject and Covid-19 infection is suspected. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because while an Axial Ion Mobility Spectrometer analyzer is used to analyze the breath of a subject, this method is monitoring the natural response (release of VOCs) by a subject to a natural infection by Covid-19.
Based upon an analysis with respect to the claims as a whole, claim(s) 1-4 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (1.e., natural phenomenon) without significantly more (these claims are interpreted in light of the most recent Guidelines (See www.uspto.gov for further guidance).
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps found at www.uspto.gov, the claims are directed to an ineligible process as further detailed below.
In this case, claim(s) 1-4 recite or are directed to a product (Step 1) and recite and intended use that is directed to judicial exceptions (in this case, natural phenomenon)(Step 2A-Prong One). The claimed apparatus requires using an axial ion mobility spectrometer (AIMS) to analyze breath from a subject in order to detect Covid-19. The AIMS will detect at least three volatile organic compounds selected from C1-C3 alcohols, C2-C8 aldehydes, C3-C4 ketones and C4-C6 alkyl esters. More specific examples of the VOCs are Ethyl butyrate, Propionaldehyde, 2-butanone, Heptaldehyde, Octanal, and Butyraldehyde. The AIMS determines a positive result on at least four of its channels that are specific for the VOCs, it is interpreted as a positive COVID-19 result. This apparatus monitors the natural response (release of VOCs) by a subject to a natural infection by Covid-19. Therefore, the AIMS is used to detect a natural phenomenon.
When considering step 2A and 2B, the claim apparatus does not recite any additional elements that integrate it into a practical application, such as treating the subject for Covid-19 if Covid-19 infection is confirmed. Applicants have amended the claimed invention to require an analyzer that comprises a heated desorber; a pre-separator in fluid communication with the desorber; a gas chromatograph, in fluid communication with the pre-separator; and a AIMS in fluid communication with the pre-separator. The analyzer also comprises an ionization chamber including chemical ionization reagents. This analyzer is used to detect VOCs present in a breath sample, which would be strongly indicative of a COVID-19 infection. However, this analyzer is also taught in Nacson et al. (US PGPub 20150160161) [see figure 1 below]
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Nacson et al. also teach that their analyzer is used to eliminate unwanted compounds and/or contaminants (such as volatile compounds), and thus to preselect for analysis compounds likely to be of interest and to detect chemical warfare agents, various organic environmental pollutants [see paragraphs 59 and 3] Additionally, CIRs are deployed in the IMS' ionization chamber to facilitate ionization of the substances in the sample for detection. [see paragraph 72] Therefore, Nacson et al. teach that the claimed analyzer is a routine and conventional device used in processing air or environmental samples.
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. The claims do not invoke any of the considerations that courts have identified as providing significantly more than the exceptions. Even when viewed as a combination, the additional elements fail to transform the exceptions into a patent eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception.
It is asserted that the claims are directed to judicial exceptions by reciting a natural phenomenon associated with a Covid-19 infection (detecting naturally occurring VOCs in a breath sample, confirm a COVID-19 infection), without reciting more or additional elements that amount to significantly more than the judicial exception. Therefore, claim(s) 1-4 and 9 do not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/ Primary Examiner, Art Unit 1671
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