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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 9 and 13 are objected to because of the following informalities:
Claim 9 reads “dependent ion profile” and should read “dependent ion profiles”.
Claim 13 reads “wherein with” and should just read “wherein”.
Appropriate correction is required.
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.
Claims 1-14 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.
Regarding Claim 1, the limitation “each-time dependent ion profile” renders the claim indefinite, because as previously stated in the claim, only a single time-dependent ion profile is received. For purposes of examination the indefinite limitation has been deemed to claim that multiple time-dependent ion profiles are received over time.
The term “a signal of interest” in claim 1 is a relative term which renders the claim indefinite. The term “a signal of interest” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the indefinite limitation has been deemed to claim a signal that is kept for classification.
Regarding Claim 4, the limitation “a compounds that is known to be present” renders the claim indefinite. It is unclear how a compound in known, by what or by who it is known by, or the criterion for determining whether the compound is known. For purposes of examination the indefinite limitation has been deemed to claim a certain type of compound in exhaled breath.
Regarding Claim 8, the limitation “integrating each selected time-dependent ion profile” lacks proper antecedent basis because a time-dependent profile is not previously selected in Claim 8 or parent Claim 1. For purposes of examination the indefinite limitation has been deemed to claim that Claim 8 is dependent upon Claim 5.
Regarding Claim 10, the limitation “consisting of mass-to-charge ratio values…” renders the claim indefinite, because if an array “consists” of only these values, then the claim has no place to store and define “signal strength” for those values. For purposes of examination the indefinite limitation has been deemed to claim “composed of…” or “comprised of…” mass=to charge ratio values.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-14 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-14 recites at least one step or instruction for a method that compares a time-varying mass-spectrometer value to a time-varying breath/exhalation profile that classifies the ion signal as exhalation-correlated (of interest) or not, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-14recites an abstract idea.
Specifically, Claim 1 recites a method that compares a time-varying mass spectrometer ion signal (at a given m/z) to a time-varying breath/exhalation profile over the same time window and classifies the ion signal as exhalation-correlated (signal of interest) or not, where the classification is based on a computer “degree of temporal correlation” between the two time series (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Further, dependent Claims 2-14 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea 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.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1 (and their respective dependent Claims 2-14) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: a computer are generically recited computer elements dependent Claim 14 which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to 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. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1(and their 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 (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., computer as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. 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 identified above in independent Claim 1 (and their 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 1-14 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: a computer (Claim 14).
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification the computer is never described as anything other than a generic computer.
Accordingly, in light of Applicant’s specification, the claimed term computer is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computer.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).
The recitation of the above-identified additional limitations in Claims 1-14 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method of Claims 1-14 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 1-14 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 Claims 1 (and their 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 1-14 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 1-14 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-14 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/160753 A1 to Vidal-De-Miguel et al. (hereinafter, Vidal) in view of Exhaled breath compositions under varying respiratory rhythms reflects ventilatory variations: translating breathomics towards respiratory medicine to Sukul et al. (hereinafter, Suklul).
Regarding Claims 1, 5, 6, 7 Vidal discloses a computer-implemented method for processing mass spectrometry data obtained from a breath gas, the method comprising inter alia:
receiving a time-dependent ion profile originating from a spectrometer data sample (paragraph [0047] “The signal intensity for each signal detected by the MS during each exhalation was computed by using the time corresponding to 3% or more of the CO2 signal…to define a single exhalation event.”) (also see paragraph [0048]), the spectrometer data sample having been recorded during at least one exhalation from a human or animal subject (paragraph [0011] “…the person (13) exhales through a mouthpiece (4) into a breathe through body (2), of the exhaled flow (12), a fraction (14) is passed to an analyzer (8)…”);
each time-dependent ion profile being associated with one mass-to-charge ratio value and comprising a signal strength for said one mass-to-charge ratio value measured over a time duration (paragraph [0045] “The MS was operated…in full MS mode (polarity: positive, scan range: 100 to 400 m/z, microscans: 4, ACG target: 106 and maximum injection time: 500 ms) with a resolution of 140,000 (at m/z 200).”);
receiving a time-dependent breath profile, the time-dependent breath profile having been recorded during said at least one exhalation over said time duration (paragraph [0029] “The Exhalation Maneuver Monitoring and Guiding device of the present invention accurately measures the time evolution of at least the exhaled flow, or the exhaled volume, or the exhaled CO2 concentration…”).
While Vidal discloses synchronization (i.e., aligning the timestamps of the MS and the CO2 sensor), Vidal does not expressly disclose (Claim 1) a temporal correlation step comprising determining a degree of temporal correlation between the time-dependent ion profile and the time-dependent breath profile, and classifying the time-dependent ion profile based on the degree of temporal correlation as either a signal of interest or a signal not correlated with the exhalation of the subject, (Claim 5) wherein the degree of temporal correlation is expressed as a correlation coefficient for each time-dependent ion profile, and wherein classifying the at least one time-dependent ion profile comprises: selecting the time-dependent ion profile if its correlation coefficient is higher than or equal to a pre-determined correlation threshold, or discarding the time-dependent ion profile if its correlation coefficient is lower than the pre-determined correlation threshold, (Claim 6) the temporal correlation step further comprising: computing a p-value associated with each correlation coefficient; computing a false discovery rate associated with each p-value, and discarding the selected time-dependent ion profile if the false discovery rate is higher than a pre-determined false discovery rate threshold, (Claim 7) wherein the correlation coefficient is Spearman's rank correlation coefficient.
However, Sukul teaches a method of real-time breath analysis using mass spectrometry and addresses the problem of identifying and filtering signals of interest from background noise and environmental conditions. Sukul teaches (Claim 1) a temporal correlation step comprising determining a degree of temporal correlation between the time-dependent ion profile and the time-dependent breath profile (see Statistical Analysis section “Correlations between VOC concentrations and respiratory parameters (p-value ≤ 0.005) were tested via Pearson Product Moment Correlation analysis.”) (see Results “In this study we measured hundreds of VOCs in real time by PTR-ToF “, “Breath-resolved time profiles of V’E, pET-CO2, isoprene and acetone are presented in Fig. 2”, “VOCs were tentatively identified based on their m/z”), and classifying the time-dependent ion profile based on the degree of temporal correlation as either a signal of interest or a signal not correlated with the exhalation of the subject (see Results “As acetone and isoprene closely mirror (positively and/or negatively) many behaviours of those two respiratory parameters [pET – CO2 and minute ventilations]… we selected these two VOCs in order to address effects of respiratory rhythms on ventilatory variations.”), (Claim 5) wherein the degree of temporal correlation is expressed as a correlation coefficient for each time-dependent ion profile (see Statistical Analysis section “Correlations between VOC concentrations and respiratory parameters (p-value ≤ 0.005) were tested via Pearson Product Moment Correlation analysis.”) (see Results “In this study we measured hundreds of VOCs in real time by PTR-ToF…”, “Breath-resolved time profiles of V’E, pET-CO2, isoprene and acetone are presented in Fig. 2”, “VOCs were tentatively identified based on their m/z”), and wherein classifying the at least one time-dependent ion profile comprises (Results “To reduce confounding effects, only compounds with expiratory abundances well above the inspiratory abundance…were selected for further analysis): selecting the time-dependent ion profile if its correlation coefficient is higher than or equal to a pre-determined correlation threshold (see Results “As acetone and isoprene closely mirror (positively and/or negatively) many behaviours of those two respiratory parameters [pET – CO2 and minute ventilations]… we selected these two VOCs in order to address effects of respiratory rhythms on ventilatory variations.”), or discarding the time-dependent ion profile if its correlation coefficient is lower than the pre-determined correlation threshold (see Introduction “…we realised that any normal but unsupervised physiological effects during sampling may override the actual pathophysiological impression in obtained data... one must maintain certain ventilatory attributes (i.e. sampling related) in any clinical study concerning breathomics.”), (Claim 6) the temporal correlation step further comprising: computing a p-value associated with each correlation coefficient (see Statistical Analysis “Correlations between VOC concentrations and respiratory parameters (p-value ≤ 0.005) were tested via Pearson Product Moment Correlation analysis.”), computing a false discovery rate associated with each p-value (see Results “Statistical validation and reproducibility in breath-resolved ventilatory variations… are presented in Supplementary Table S2”, Examiner notes Standard MS validation routinely uses FDR to correct for multiple testing across hundreds of ions), and discarding the selected time-dependent ion profile if the false discovery rate is higher than a pre-determined false discovery rate threshold (FIG. 3 description “Statistical significances were tested by means of repeated measurement-ANOVA on ranks (p-value ≤ 0.005). From all pairwise-multiple comparisons, statistically indifferent (i.e. with no significant differences and thereby, reproducible) respiratory rhythms are marked with red-coloured ovals.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Vidal with the temporal correlation step, including the determination step and classification of Sukul, as Sukul teaches this would have ensured that only signals truly mirror the CO2 profiles are retained as signals of interest (see Introduction “We have learned that in order to minimize/discriminate physiological variations, one must maintain certain ventilatory attributes (i.e. sampling related) in any clinical study concerning breathomics.”). Furthermore, switching from the Pearson to Spearman correlation coefficient would have been obvious to a skilled artisan, as this would have been simple substitution of one choice of a correlation coefficient for biological data that is non-linear or contains outliers for another.
Regarding Claim 2, Vidal in view of Sukul teach the method of claim 1, wherein the time-dependent breath profile is a time- dependent total ion profile derived from the spectrometer data sample (Vidal: paragraph [0030] “…an ion analyzer (24) that analyzes the physical properties of said ions… where ionized breath metabolites are analyzed in real-time.) (Vidal: paragraph [0047] “…the integrated area under the curve (AUC) for all MS signals was normalized… This normalized AUC can be considered as breath signal of metabolites (i.e. features).”)
Regarding Claim 3, Vidal in view of Sukul teach the method of claim 1, wherein the time-dependent breath profile is a capnogram, the capnogram having been measured simultaneously with the spectrometer data sample (Vidal: paragraph [0035] “By logging the exhaled CO2 concentration with the Exhalation Maneuver Monitoring and Guiding device… it is possible to differentiate where a particular fraction of an exhalation is coming from.” and paragraph [0013] “…synchronizing the data produced by the set of sensor probes (10) with the data produced by the analyzer (8)…”).
Regarding Claim 4, Vidal in view of Sukul teach the method of claim 1, wherein the time-dependent breath profile is a time-dependent ion profile of a compound that is known to be present in the breath gas of the human or animal subject during the at least one exhalation (Vidal: paragraph [0049] “…we concentrated in discussing our findings for a series of three classes of fatty aldehydes… These 27 representative metabolites were used as benchmarking metabolites.” and [0046] “To guide the maneuver, the subjects could monitor in real-time their CO2 level, flow rate and total exhaled volume… Raw data from the MS and Exhalation Maneuver Monitoring and Guiding device were exported, synchronized and processed.”)
Regarding Claim 8, Vidal in view of Sukul teach the method of Claim 1, further comprising:
an integration step, the integration step comprising integrating each selected time-dependent ion profile over an integration time to obtain an integrated signal strength (Vidal: paragraph [0047] “…the integrated area under the curve (AUC) for all MS signals was normalized by the exhaled volume in the exhalation (calculated by integrating the flow over time in a particular exhalation from the Exhalation Maneuver Monitoring and Guiding device data)…), a normalization step, the normalization step comprising normalizing each integrated signal strength by said integration time to obtain a normalized signal strength (Vidal: paragraph [0047] “Signal intensities were normalized by considering exhalation windows… signal intensity for each signal detected by the MS during each exhalation was computed…”, creating a feature list comprising the mass-to-charge ratio values (M2) and their associated normalized signal strengths for said spectrometer data sample, and adding the feature list to a final data matrix (Vidal: paragraph [0047] “ This normalized AUC can be considered as breath signal of metabolites (i.e. features).” ) (paragraph [0061] “In order to assess whether our system showed any significant batch effect…we analyzed our data using principal components analysis (PCA).”).
Regarding Claim 14, Vidal in view of Sukul teach a computer program product comprising instructions which, when the program is executed by a computer, cause the computer to carry out the method of any one of the preceding claims (paragraph [0033]).
Allowable Subject Matter
Claims 9-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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, Jacqueline Cheng can be reached at (571)272-5596. 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.
/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791