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 .
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 claims are directed either to a method/process or to a system/machine.
Step 2A, Prong One: The claims recite a mental process including steps such as “determine a characteristic nociception parameter …” and “determine … a nociception event …” (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 step of “monitor a nociception parameter …” is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process; the step of “provide an indication …” is considered insignificant post-solution activity since it merely outputs the result of the mental process using a generic output modality. Furthermore, merely carrying out mental steps using generic computing technology such as “memory” and “processing circuitry” 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 (specifically “memory” and “processing circuitry” and “non-transitory computer readable storage medium”). 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. The Zuckerman reference cited in this action also demonstrates the use of these conventional computer elements. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
Independent claims 12 and 20 follow the same analysis above since they are substantially identical in scope.
All dependent claims also follow the same analysis above since all of the dependent claims merely further define the mental steps themselves, e.g. by adding additional mental steps such as weighting or averaging numerical values.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6, 12-14, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2018/0310877 A1 to Zuckerman Stark et al. (hereinafter “Zuckerman”).
Regarding Claims 1, 12 and 20, Zuckerman teaches a system comprising:
Memory (see e.g. Paras. 234 and 236) configured to store a nociception threshold (see “threshold” in e.g. Paras. 33, 105: “when the NS value crosses a predefined threshold value nociception is identified”, and 114); and
processing circuitry (see e.g. the abstract and 110a and/or 110b in FIGS. 1A-B; see e.g. Para. 97: “According to some embodiments, the nociception/analgesia monitoring device includes a processor and/or other computing unit. According to some embodiments, the computing unit may be a computing circuity. According to some embodiments, the computing unit may be a remote processing unit such as, but not limited to, a mobile device, smartphone, tablet pc, miniaturized computing device, system on chip, a cloud or the like”) configured to:
monitor a nociception parameter (see e.g. Para 93: “at least one or more physiological features that may be extracted and/or derived from sensor signals” – the extracted and/or derived features are equivalent to the claimed “nociception parameter”) of a patient during a medical procedure, wherein the nociception parameter is based at least in part on one or more sensed physiological signals of the patient (see e.g. Para 93: “at least one or more physiological features that may be extracted and/or derived from sensor signals”);
determine a characteristic nociception parameter (“nociception scale (NS) value” in e.g. Para. 13, 99) at a point in time based at least in part on values of the nociception parameter over a period of time (see e.g. Para. 92: “According to some embodiments, the at least three physiological parameters may refer to a derivative and/or features of the parameter, a moving average of the parameter, a value of the parameter or its derivative obtained during a moving window, derivatives of the parameter in time and the like. According to some embodiments, a derivative of the parameter may refer to any value derived from the parameter by filtering, averaging, and/or other mathematical or statistical processing”);
determine, based at least in part on comparing the characteristic nociception parameter at the point in time with the nociception threshold, a nociception event has occurred at the point in time (see e.g. Paras. 105, 114); and
provide an indication to adjust an amount of analgesic administered to the patient based on the determination that the nociception event has occurred at the point in time (see e.g. Para. 115).
Regarding Claims 2 and 13, see e.g. Paras. 105, 114; also, as explained in Para. 115, the determination of the event can either be the NS value going above or below the threshold, depending on the scale.
Regarding Claims 3 and 14, see e.g. see e.g. Para. 92: “According to some embodiments, the at least three physiological parameters may refer to a derivative and/or features of the parameter, a moving average of the parameter, a value of the parameter or its derivative obtained during a moving window, derivatives of the parameter in time and the like. According to some embodiments, a derivative of the parameter may refer to any value derived from the parameter by filtering, averaging, and/or other mathematical or statistical processing.
Regarding Claim 4, see e.g. Paras. 92, 104, 141 (parameters can be weighted and averaged over time).
Regarding Claim 6, see e.g. Para. 104 (lower weights can be given to certain parameters during certain noisy time periods, e.g. for parameters known to be affected by administration of a certain medication).
Regarding Claim 16, see e.g. Paras. 92, 104 (lower weights can be given to certain parameters during certain noisy time periods, e.g. for parameters known to be affected by administration of a certain medication), 141 (parameters can be weighted and averaged over time).
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 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zuckerman in view of US 6,317,627 B1 to Ennen et al. (hereinafter “Ennan”).
Regarding Claims 5 and 15, Zuckerman teaches a weighted average of the nociception parameter as discussed above, but fails to specifically teach weighting the values based at least in part on a recency of the values. However, this methodology was known in the art. For example, Ennen teaches an analogous anesthesia monitoring system in which a patient’s EMG response is measured to produce an EMG index as an indicator of pain, and in which newer EMG data is weighted more heavily than older EMG data (see e.g. Col. 5 line 62 through Col. 6 line 6). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zuckerman to weight more recent data more heavily, as seen in Ennan, because it would enhance the accuracy of the overall determination by placing a greater emphasis on more relevant data.
Claims 10-11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zuckerman in view of US 20180126104 A1 to Kruger et al. (hereinafter “Kruger”).
Regarding Claims 10-11 and 19, Zuckerman fails to specifically teach that the characteristic parameter and/or determination to administer analgesic is based at least in part on an integral of the values of the nociception parameter over the period of time that are greater than or equal to the nociception threshold. However, this methodology for detecting a particular medical event was known in the art. For instance, Kruger teaches that this same methodology can be used for evaluating numerous different types of parameters for detecting an event (see e.g. Paras. 81, 83, 85). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zuckerman to analyze the integral of the values of the nociception parameter over the period of time that are greater than or equal to the nociception threshold because it would involve merely selecting an incorporating a known mathematical analysis technique for detecting an event from a series of physiological data collected over time.
Claims 7-9 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zuckerman in view of US 2014/0121541 A1 to Demmer et al. (hereinafter “Demmer”).
Regarding Claims 7-9 and 17-18, Zuckerman fails to specifically teach that the characteristic nociception parameter (i.e. the NS value, which may be the weighted average of extracted features of physiological parameters over time) is determined as a weighted sum of the most recently determined characteristic nociception parameter and the value of the nociception parameter. However, this same methodology was known to be useable to calculate an average over time metric for any repeated event measure, as seen in Demmer (see e.g. Para. 45: “The above equation may be generalized to a long-term average metric of any repeated event measure where the long-term average (or other centeredness) metric is updated as a sum of a weighted combination of the stored long-term average metric and a current measurement of the repeating event; also see Para .42). Demmer’s “stored long-term average metric” is equivalent to the claimed “most recently determined characteristic nociception parameter” here, whereas Demmer’s “current measurement of the repeating event” is equivalent to the claimed “nociception parameter at the point in time” here. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zuckerman to incorporate the calculation seen above in Demmer for calculating an updated characteristic nociception parameter, because it would involve merely selecting an incorporating a known mathematical analysis technique for detecting an event from a series of physiological data collected over time.
Conclusion
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