DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on April 24, 2026 were received and fully considered. Claims 1, 6, and 11 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method of detecting stage one lung cancer in a subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“…quantifying a concentration of the at least one of Acetoin, Dodecane, and p-Cymene by comparing mass spectrometry data for the separated VOCs to a calibration curve…”
These limitations describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…receiving a breath sample from the subject; transferring the breath sample to a thermal desorption system to extract volatile organic compounds (VOCs) from the breath sample; analyzing the extracted VOCs using a gas chromatograph mass spectrometer system (GC-MS) to separate the VOCs using gas chromatography and to detect at least one of Acetoin, Dodecane, and p-Cymene in the separated VOCs using mass spectrometry… initiating a follow-up plan for the subject when the quantified concentration of the at least one of Acetoin, Dodecane, and p-Cymene exceeds a predetermined threshold concentration
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception and outputting do not integrate a judicial exception into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they pertain to widely-understood, routine, and conventional techniques for obtaining data. Moreover, “receiving a breath sample from the subject” is highly generalized. Furthermore, Examiner takes official notice that it is widely known to utilize a gas chromatograph mass spectrometer system for separation and analysis of various VOCs.
Independent claim 11 is also not patent eligible for substantially similar reasons.
Dependent claims 2-10 and 12-17 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-17 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hanada et al. (US PG Pub. No. 2018/0275131 A1) (hereinafter “Hanada”) in view of Hanna et al. (US PG Pub. No. 2022/0221443 A1) (hereinafter “Hanna”).
Hanada was applied in the previous office action.
With respect to claims 1 and 11, Hanada teaches a method of detecting stage one lung cancer in a subject (par.0305-0306) comprising: receiving a breath sample from the subject (par.0306).
However, Hanada does not teach transferring the breath sample to a thermal desorption system to extract volatile organic compounds (VOCs) from the breath sample; analyzing the extracted VOCs using a gas chromatograph mass spectrometer system (GC-MS) to separate the VOCs using gas chromatography and to detect at least one of Acetoin, Dodecane, and p-Cymene in the separated VOCs using mass spectrometry; quantifying a concentration of the at least one of Acetoin, Dodecane, and p-Cymene by comparing mass spectrometry data for the separated VOCs to a calibration curve; initiating a follow-up plan for the subject when the quantified concentration of the at least one of Acetoin, Dodecane, and p-Cymene exceeds a predetermined threshold concentration.
Hanna teaches biomarker detection for cancer diagnosis and prognosis (see title); and transferring the breath sample to a thermal desorption system to extract volatile organic compounds (VOCs) from the breath sample (par.0105 “VOCs from breath bags are then preferably pre-concentrated onto thermal desorption tubes by transferring breath across the tubes”); analyzing the extracted VOCs using a gas chromatograph mass spectrometer system (GC-MS) to separate the VOCs using gas chromatography (par.0109 “signature compounds can be reliably detected using gas chromatography, mass spectrometry”) and to detect at least one of Acetoin, Dodecane, and p-Cymene in the separated VOCs using mass spectrometry (par.0093 “the signature compound may be… dodecane”; see also Figs. 12C, 15C, 18, 21A, 23, 32C, 34C); quantifying a concentration of the at least one of Acetoin, Dodecane, and p-Cymene by comparing mass spectrometry data for the separated VOCs to a calibration curve (Abstract “comparing this concentration with a reference for the concentration of the signature compound in an individual who does not suffer from cancer”; par.0093 “the signature compound may be… dodecane”; see also Figs. 12C, 15C, 18, 21A, 23, 32C, 34C); initiating a follow-up plan for the subject when the quantified concentration of the at least one of Acetoin, Dodecane, and p-Cymene exceeds a predetermined threshold concentration (abstract “an increase or decrease in the concentration of the signature compound compared to the reference, suggests that the subject is suffering from cancer”; par.0063 “administering… a therapeutic agent… which prevents, reduces or delays progression of cancer”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Hanada to incorporate detecting at least one of Acetoin, Dodecane, and p-Cymene using a gas chromatograph mass spectrometer system, in the manner recited, in order to provide indication as to whether a patient suffers from cancer via alternate non-invasive means, as suggested by Hanna (abstract). Moreover, PHOSITA would have had predictable success combining Hanada and Hanna as both references relate to the same narrow field of endeavor, i.e. cancer detection via analysis of VOCs in exhaled breadth.
With respect to claims 2 and 12, Hanada teaches further comprising receiving multiple breath samples from the subject (par.0024,0026).
With respect to claims 3 and 13, Hanada teaches using a device for analysis of the VOCs in the breath (par.0028, 0030, 0110-0111).
With respect to claims 4 and 14, Hanada does not explicitly teach further comprising using the device more than once, in order to confirm results. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed for several reasons. First, Hanada teaches uses a device (e.g. chromatograph) to analyze the components (par.0027-28). Moreover, it is widely known, in diagnostics, to confirm results, get a second opinion (especially when cancer is the potential diagnosis) based on obtained data, etc. Therefore, PHOSITA would have had predictable success modifying Hanada to use the device more than once, in order to confirm results in order to provide more accuracy in the cancer diagnosis, as evidence by Hanada, and generally known in the art.
With respect to claim 5, Hanada teaches collecting the breath sample in a bag or other receptacle (collecting device 8 in Fig. 3).
With respect to claim 6, Hanna teaches wherein the bag or other receptacle comprises a film bag (steel breath bag in Fig. 1). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Hanada to incorporate a film bag as this would be a simple substitution allowing for obtaining VOCs from exhaled breath in an alternate manner that has been set forth in the art, as evidence by Hanna (Fig. 1).
With respect to claims 7 and 15, Hanada does not explicitly teach further comprising analyzing the breath sample within 24 hours of collection. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed for several reasons. First, Hanada inherently teaches analyzing the breath sample within some time period (abstract “assessed in short time”). Accordingly, PHOSITA would have had predictable success modifying Hanada to analyze the breath sample within 24 hours of collection since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claims 8 and 16, Hanada does not explicitly teach further comprising analyzing the breath sample within 2 hours of collection. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed for several reasons. First, Hanada inherently teaches analyzing the breath sample within some time period (abstract “assessed in short time”). Accordingly, PHOSITA would have had predictable success modifying Hanada to analyze the breath sample within 2 hours of collection since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claims 9 and 17, Hanada teaches further comprising using a gas chromatograph for analysis of the breath sample (par.0027).
With respect to claim 10, Hanada does not explicitly teach wherein the follow up plan further comprises additional testing, treatment, preventative and/or lifestyle changes. However, further modification to include additional testing, treatment, preventative and/or lifestyle would have been prima facie obvious to PHOSITA when the invention was filed for several reasons. First, Hanada discloses calculating an assessment score from results of the received exhaled air sample, concentrations of plurality of types of target components, etc. (see par.0342). Moreover, it is widely known to provide targeted therapy/treatment recommendations based on the patient’s assessment score, diagnostic result, etc. Therefore, PHOSITA would have had predictable success modifying Hanada when the invention was filed to further incorporate initiating additional testing, treatment, preventative and/or lifestyle changes for the purposes tailoring subsequent therapy/treatment to the particular cancer-stricken patient, as suggested by Hanada and is widely known in the art.
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 112B rejections raised in the previous office action were persuasive in view of amendment. Therefore, these rejections are withdrawn.
Applicant’s arguments filed with respect to the 35 USC 101 rejections raised in the previous office action were fully considered, but they were not persuasive. Examiner maintains that the claims, when considered as an ordered combination, recites a judicial exception that is not integrated into a practical application; while the new additional limitations do not recite significantly more. While the current amendment is greatly appreciated, the amendment merely further limits the abstract idea and/or recites additional limitations that pertain to mere extra-solution activity. For instance, Examiner argues reciting a highly generalized gas chromatograph mass spectrometer system, as set forth in the current amendment, fails to integrate the claims into a practical application as this merely amount to extra-solution activity1. Furthermore, a gas chromatograph mass spectrometer system does not amount to a particular machine as it is recited at a high level of generality, and also it widely known to utilize a gas chromatograph mass spectrometer system to detect VOCs, cancer, etc. in exhaled breadth. See prior art cited at the end of the current office action for example teachings. For at least these reasons, the 35 USC 101 rejections are maintained.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art rejection above for more detail, updated citations (new secondary reference, Hanna), and updated obviousness rationale.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent No. 5996586: see col. 2, lines 7+ “A portable microprocessor-controlled breath collection apparatus collects alveolar breath VOCs onto sorbent traps which are then analyzed by conventional gas chromatography and mass spectroscopy.”
US Patent No. 6248078: see col. 15, lines 49+ “a conventional gas chromatography (GC) system that is able to detect volatile organic compounds”
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 MPEP 2106.05(g) mere data gathering does not integrate claims into a practical application.
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