DETAILED ACTION
Response to Arguments
Applicant’s arguments filed 2/24/2026 with respect to 35 U.S.C. 101 rejections of Claims 7 and 10 (and respective dependent claims) have been fully considered and are persuasive. The 35 U.S.C. 101 rejections of Claim 7 and 10 (and respective dependent claims) have been withdrawn.
Applicant's arguments filed 2/24/2026 have been fully considered but they are not persuasive. The Applicant argues that the subject matter of Claim 1 cannot be performed in the human mind. The Examiner disagrees and respectfully submits that these arguments are not persuasive because the rejection is based on Claim 1 reciting both an abstract idea (a practitioner is can mentally receive such indole data to determine blood glucose) and also a law of nature. It is noted that the correlation between indole levels in exhaled breath and blood glucose levels in naturally occurring. The rejection of Claims 1, 2, 6 and 11 are maintained. However, the Examiner notes that dependent claims other than 2, 6 and 11 resolve these 35 U.S.C. 101 issues.
Claim Objections
Claim 14 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 6 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception including both a law of nature and an abstract idea without significantly more. Each of Claims 1, 2, 6 and 11 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1, 2, 6 and 11 recite at least one step or instruction for determining a subject’s blood glucose level, which is grouped as a mental process under the 2019 PEG. Furthermore, the process of determining a subject’s blood glucose level based on the volatile organic marker of indole is directed to a law of nature. Accordingly, each of Claims 1, 2, 6 and 11 recite an abstract idea and a law of nature.
Specifically, Claim 1 recites non-invasively detecting indole from a subject’s exhaled breath and determining a subject’s blood glucose based a negative correlation of an amount of indole in the subject’s breath and respective dependent claims suggest further methods in which the indole and other VOCs are collected, processed and analyzed and used to determine blood glucose (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG). A practitioner is capable of reviewing indole and VOC results from indole breath collection in their mind, calculating a negative correlation and other metrics in their in their mind, and then, based on the negative correlation, determine a blood glucose level. Furthermore, the practice of the sole detection of indole to determine a blood glucose is drawn to a law of nature, because indole is directly associated with blood glucose.
Further, dependent Claims 2, 6 and 11 merely include limitations that either further define the abstract idea and law of nature (and thus don’t make the abstract idea any less abstract or remove the claim for a law of nature ) or amount to no more than generally linking the use of the abstract idea and law of nature to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea and a law of nature.
Step 2A, Prong 2
The above-identified abstract idea and law of nature in independent Claim 1 (and respective dependent Claims 2, 6 and 11) is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. The additional elements of detection by mass spectrometry, a volatile organic marker detecting system, a vapor distribution member and a processing unit merely sets forth generic detection and distribution members for the monitoring system. Therefore there is no improvement of the functioning of a computer, or any other technology or technical field nor are there additional elements that apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation 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. For at least these reasons, the abstract idea identified above in independent Claim 1 (and respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea and law of nature, using rules (e.g., computer instructions) capable of execution in the human mind. In other words, these claims are merely directed to an abstract idea capable of being performed within the human mind. 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. Thus, for these additional reasons, the abstract idea and law of nature identified above in independent Claim 1 (and respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1, 2, 6 and 11 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims do not require additional elements, because no additional elements have been claimed
Regarding Claims 1, 2, 6 and 11, the additional elements of the detecting system and distribution center are defined as associated components as set forth in paragraphs [0052] and [0053] of the instant application and in paragraph [0016], respectively and appear to be generic components for the detection and distribution aspects of the method. Furthermore, Applicant’s specification does not describe any special programming or algorithms. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
For at least the above reasons, the method of Claims 1, 2, 6 and 11 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1, 2, 6 and 11 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 (and dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-10 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1, 2, 6 and 11 amount to significantly more than the abstract idea itself. Accordingly, Claims 1, 2, 6 and 11 are not patent eligible and rejected under 35 U.S.C. 101.
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.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791