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 .
Response to Arguments
I. Claim Objections
Applicant’s claim amendments have successfully overcome the previous objections. Those objections are withdrawn.
II. Claim Rejections under 35 U.S.C. § 112
Applicant’s claim amendments have successfully overcome the previous rejections under § 112. Those rejections are withdrawn.
III. Claim Rejections under 35 U.S.C. § 101
Applicant’s remarks concerning the previous § 101 rejections have been fully considered but are not persuasive.
Applicant first argues that eligibility is self-evident under the streamlined § 101 analysis because the claims require a plurality of signals from specific types of sensors. The Examiner respectfully disagrees. Collecting data via sensors can be (and is, in this case) a form of insignificant pre-solution activity, as explained in more detail below. A claim would not have self-evident eligibility merely because it includes insignificant pre-solution activity. However, more importantly, as noted in MPEP § 2106.06, “the results of the streamlined analysis will always be the same as the full analysis, thus the streamlined analysis is not a means of avoiding a finding of ineligibility that would occur if a claim were to undergo the full eligibility analysis”. As such, as noted in that section, when there is any doubt or dispute as to subject matter eligibility, the full analysis is used.
Applicant next argues that the claims here do not recite a mental process because the claims include features that cannot be performed by the human mind. Specifically, Applicant argues that the steps of obtaining multimodal signals from one or more contact electrodes and one or more bioimpedance spectroscopy electrodes cannot be performed in the human mind. The Examiner respectfully disagrees because these limitations are insignificant pre-solution activity, not part of the mental process itself. Under the § 101 analysis for a claim that recites a mental process, it is not required that every limitation of the claim be capable to be performed mentally. Rather, the analysis separately looks at the limitation(s) that qualify as the mental process, and additional limitations such as insignificant extra-solution activity (e.g. pre-solution activity of data gathering via sensors). There is no requirement under the § 101 analysis that the additional limitations be performed entirely mentally.
Applicant next argues that the claims here integrate the mental process into a practical application because the claims use a “particular machine” as allegedly evidenced by the recited sensor types. The Examiner respectfully disagrees. As noted in MPEP § 2106.05(b), the “particular machine” analysis considers, among other things, the particularity or generality of the elements of the machine, and whether its involvement is extra-solution activity. Here, the sensor types are claimed in a general manner by name only, e.g. “contact microphone” and “bioimpedance spectroscopy electrodes.” Furthermore, their claimed use is merely to collect the data necessary to carry out the otherwise mental process, and thus the sensors are merely insignificant pre-solution activity. As such, the fact that the claim recites certain types of sensors does not mean that the claim is eligible for using a “particular machine.”
Applicant next argues that the claims here amount to an improvement in a computer-related technology simply because it can “improve the sensitivity of respiratory assessment.” The Examiner respectfully disagrees. To the extent that Applicant’s claims recite an improvement in this regard, it is an improvement due to the mental process of combining the recited sensor signal types, not due to any change or improvement in technology. Utilizing existing technology to perform a mental process that achieves a desirable outcome does not necessarily mean that the technology itself was improved.
Finally, under step 2B, Applicant argues that claims here recite “significantly more” due to fusing multiple modalities of sensing into a single recording/monitoring system to improve specificity and sensitivity. The Examiner respectfully disagrees. It is well-understood, routine and conventional to combine multiple sensor types for multimodal medical diagnostic analysis. The claims here otherwise recite generic and conventional components, including the sensor types recited and the processing technology. As such, there is nothing claimed that qualifies as “significantly more” than the mental process itself.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
Step 1: All of claims 1-20 are directed either to a method or to a system.
Step 2A, Prong One: The claims recite a mental process including data evaluation steps such as “generating … values for (i) at least one of a first set of a plurality of statistical features and a first set of time-frequency domain features using the obtained one or more lung acoustic signals, and (ii) at least one of a second set of a plurality of statistical features and a second set of time-frequency domain features using the obtained one or more bioimpedance spectroscopy signals; and generating … a respiratory health value representative of a respiratory health of the patient by application of the values of the first and second sets of plurality of statistical features and time-frequency domain features” (see e.g. claim 1) which could be performed by the human mind and/or by a human with a physical aid such as pen and paper.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the steps of gathering the BIS/acoustic/temperature/inertial data are considered insignificant pre-solution activity of mere data gathering, since they merely collects the data necessary to carry out the mental process using generic and known sensor modalities; the output steps of generating audible or visual alerts using a speaker or display and/or a message notification are considered insignificant post-solution activity since they merely output the result of the mental process using generic output modalities. Furthermore, merely carrying out mental steps using generic computing technology such as “a processor” or “an analysis system” or “trained classifiers” is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components and generic data collection and output components. The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2018/0280646 A1 to Freeman et al. is relevant for the reasons summarized in the incoming written opinion for PCT/US2021/049783 filed by Applicant on March 10, 2023 (note: the written opinion refers to the WO publication, however the same teachings are present).
US 2017/0147773 A1 to Van De Stolpe et al. teaches a multimodal system including bioimpedance spectroscopy for lung evaluation (see e.g. Para. 50).
Beckmann et al. (Beckmann L, van Riesen D, Leonhardt S. Optimal electrode placement and frequency range selection for the detection of lung water using bioimpedance spectroscopy. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:2685-8. doi: 10.1109/IEMBS.2007.4352882. PMID: 18002548) is considered generally relevant for showing that it was known to use BIS for detecting lung fluid.
THIS ACTION IS MADE FINAL. 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 JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792