DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-12are is rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 1-12 recites a series of steps and therefore, falls under the statutory category of being a process. See MPEP 2106.03.
2A – Prong 1: The independent claims 1 and 12 recite a judicial exception by reciting the limitations of “obtaining a plurality of samples”, “quantifying an additive exposure”, “assigning an exhaled carbon monoxide level”, “receiving an input data”, “recording a time of the input”, “identifying one or more trends”, “providing an intervention”, “correlating the intervention vs the one or more trends”, “track an effect of the intervention”, “determine an efficacy”, “adjusting the intervention”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claims 1 and 12 recite the additional limitations of “portable detector”, “processor”, “displaying”. The mentioned limitations are recited at a high level of generality and is recited as performing generic computer functions. i.e., data processing. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 2-11 depend on claim 1. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the dependent claim recites the limitations “sequentially obtaining the samples”, “correlating the exhaled carbon monoxide level versus time”, “generating a signal to the user to provide at least one sample”, “alerting the individual”, “input data including number of cigarettes smoked”, “temporally correlating”, “annotating a plot”, etc. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. The dependent claims also include the limitations of “portable sensor”, “electronic device”, which are recited at a high level of generality and is recited as performing generic computer functions. i.e., data collection, data processing and display. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
The additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Thus, claims 1-12 are directed to an abstract idea and are therefore rejected.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-5, 7, 9-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Pat Pub No. 20010037070 granted to Cranley et al. (hereinafter “Cranley” – on IDS) in view of US Pat Pub No. 20050081601 granted to Lawson (on IDS) in yet further view of US Pat Pub No. 20070072156 granted to Kaufman et al. (on IDS).
Regarding claims 1 and 12, Cranley discloses a method of quantifying an individual's smoking behavior (para [0032] “method”, para [0014]), the method comprising: obtaining a plurality of samples of exhaled air received via a detector from the individual over a period of time (para [0020], “multiple samples”, claim 23 “taking first and second breath sample”) in which a collection time is associated with each sample of exhaled air (claims 24-25 “associating a time from a clock with said breath component signals”, para [0006], [0020]); quantifying an additive exposure of via a processor in communication with the detector from each of the samples of exhaled air over the period of time (claims 23 and 27, “analyzing breath component”, para [0021], [0023]) and assigning a level to an interval of time within the period of time based on quantifying the additive exposure (claim 29, para [0020], determining a particular change in breath, para [0018] “results”, para [0021]); receiving an input data from the individual and recording a time of the input data, wherein the input data comprises information about lifestyle events of the individual (para [0037] “user or patient to enter certain data through the microcomputer user interface, including diet information, state of health, amount and duration of recent exercise…”); displaying the level based on the plurality of samples over at least a portion of the interval of time (para [0018] “reports the result”, para [0022], “transmitting result to attending physician”; para [0014] “displaying data”); identifying one or more trends based on the level (para [0020] “trend analysis”).
Cranley discloses a personal computer configured to analyze breath component to generate baseline status for the patient and to detect and analyze acute variations with respect to other user input data (Cranley para [0006]). However, Cranley fails to explicitly disclose wherein the detector is configured to be portable so as to be carried by the individual; determining and display level of exhaled carbon monoxide of the sample.
Lawson teaches a device, in a similar field of endeavor of the system above, that is portable and is configured to be carried by the individual (para [0034] “portable apparatus is hand holdable”, para [0009]). The device allows for capturing a plurality of samples of exhaled air received (para [0004], person breathing into apparatus 2) and to detect an additive exposure of exhaled carbon monoxide via a processor (para [0023]-[0029]). This allows for providing a portable device for giving the result of the measured carbon monoxide on the person's breath (para [0023] and [0031]) in order to further diagnose the patient’s breath component (Cranley [para 0014]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Cranley with the teachings of Lawson to provide the predictable result of providing a portable device for measuring carbon monoxide on the person's breath (Lawson) in order to further diagnose the patient’s breath component (Cranley, para [0014]).
Cranley as modified by Lawson renders the limitation above obvious. Cranley discloses providing an input data which includes information about lifestyle events of the individual, and identifying trends (see rejection above). However, Cranley as modified by Lawson fail to disclose providing an intervention which is customized to the individual; correlating the intervention versus the one or more trends in smoking behavior; tracking an effect of the intervention over time to determine an efficacy of the intervention in reducing the smoking behavior; and adjusting the intervention.
Kaufman teaches a similar method to support a user adopting healthy habits and behaviors. A behavior plan is mapped out to quit smoking (i.e., smoking cessation). After the plan is created, the user executes the plan. The system then monitors the user’s behavior as the user is executing the behaviors or after the user has completed the behavior and monitors the user’s results in order to improve intervention with a user if issues arise with the user (para [0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Cranley as modified by Lawson with the teachings of Kaufman to provide a behavior plan and monitor the results in order to provide the predictable result of improving intervention with a user.
It is understood that the behavior plan can be changed occasionally or as necessary to continue the efficacy of the intervention.
Regarding claim 2, Cranley as modified by Lawson and Kaufman (hereinafter “modified Cranley”) renders the method of claim 1 obvious as recited hereinabove, Cranley discloses wherein obtaining the plurality of samples comprises sequentially obtaining the plurality of samples of exhaled air (Claim 23, para [0020]).
Regarding claim 3, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Cranley discloses wherein quantifying the additive exposure comprises correlating the exhaled level versus time over the interval of time (para [0020]) to provide baseline and trend analysis, while Lawson teaches measuring carbon monoxide on a person’s breath (abstract, para [0009]; see analysis of claim 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of ‘modified Cranley’ with the teachings of Lawson to provide the predictable result of providing a portable device for measuring and displaying carbon monoxide on the person's breath (para [0023] and [0031]) along with a disincentive message (para [0019]).
Regarding claim 4, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Cranley discloses further comprising generating a signal to the individual to provide at least one sample of exhaled air (Claim 23, para [0023] “a sample would be received from the patient at step 56” and para [0027] “if necessary, an additional sample 94 requested of the patient before the test 86 is performed again”).
Regarding claim 5, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Cranley discloses further comprising alerting the individual on a repeating basis to provide each of the plurality of samples over the period of time (Claim 23-24, para [0023] additional sample may be requested”, para [0027] “additional samples may be requested again”).
Regarding claim 7, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Cranley discloses further comprising temporally correlating the information about lifestyle events to the plurality of samples of exhaled air (para [0037] discussing using user data (i.e., lifestyle) to better understand “the significance of an acute change in breath component or provide important information for a healthcare provider”; para [0038] “report”).
Regarding claim 9, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Lawson teaches where obtaining the plurality of samples further comprises using a portable sensor to obtain the samples of exhaled air (para [0031], [0039] “portable apparatus is hand holdable”, “carbon monoxide sensor 12 of the apparatus”) which allows for providing a portable carbon monoxide sensor with the portable device to measure the carbon monoxide on the person's breath (para [0023], [0031], and [0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of ‘modified Cranley’ with the additional teachings of Lawson to provide the predictable result of providing a portable sensing device for measuring carbon monoxide on the person's breath (para [0023], [0031], and [0039]), and to use the additional information by the breath component analyzer to generate baseline status for the patient and to detect and analyze acute variations with respect to other user input data (Cranley para [0006]).
Regarding claim 10, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Cranley discloses further comprising transmitting the level to an electronic device (para [0006], “acquired data can be reported … transmitted electronically to a physician or health care provider” para [0033]). Lawson teaches the level to be carbon monoxide level (para [0023] and [0031]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of ‘modified Cranley’ with the teachings of Lawson to provide the predictable result of providing measured carbon monoxide on the person's breath (para [0023], [0031], and [0039]), and to use the additional information by the breath component analyzer to generate baseline status for the patient and to detect and analyze acute variations with respect to other user input data (Cranley para [0006]).
Regarding claim 11, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Kaufman teaches further comprising obtaining a result of a behavioral questionnaire from the individual and displaying the result of the behavioral questionnaire with the exhaled carbon monoxide level (para [0091], [0105]) in order to create a personalized user profile (para [0091]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of ‘modified Cranley’ with the teachings of Kaufman to provide the predictable result of creating a personalized user profile (para [0091]). Lawson teaches displaying the exhaled carbon monoxide level (para 0023 and 0031; see rejection of claim 1).
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over modified Cranley, and further in view of Non-Patent Literature titled “Expired air carbon monoxide accumulation and elimination as a function of number of cigarettes smoked” to Henningfield et al. (hereinafter “Henningfield” – on IDS).
Regarding claim 6, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Cranley discloses performing a quantitative test on the breath samples (para [0023] “quantitative tests”) but fails to disclose providing at least a count of a number of cigarettes smoked by the individual. Henningfield teaches the input data comprises at least a count of a number of cigarettes smoked by the individual. The data can be used to verify the data by using information by self-reporting (pg. 265 “time spent smoking or number of puffs taken”). Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the modified Cranley with the teachings of Henningfield to monitor the number of cigarettes smoked by the individual in order to verify the CO levels since the CO level and number of cigarettes smoked are directly correlated (Henningfield: page 265).
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over modified Cranley, and further in view of International App No. WO2008006150 A1 granted to Nicolls et al. (on IDS).
Regarding claim 8, modified Cranley renders the method of claim 1 obvious as recited hereinabove, Cranley discloses wherein displaying the level (para [0038] “report”; see rejection of claim 1] while Lawson teaches measuring the carbon monoxide on the person's breath (para [0023] and [0031]; see rejection of claim 1), but fails to disclose annotating a plot.
Nicolls teaches a similar method for monitoring a physiological data captured in real-time (abstract) having a graphical user interface (GUI) to provide the chart, graph, timeline annotations, data logging and session data (page 12, lns 25-28) to coaching or medical staff to increase the effectiveness of training (page 2, lns 22-23). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘modified Cranley’ with the teachings of Nicolls to provide the predictable result of displaying various useful information to the coaching or medical staff to increase the effectiveness of training (page 2, lns 22-23).
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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