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 § 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.
Claim(s) 1-3, 7-10, 12-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0192941 (“Annoni”) in view of U.S. Publication No. 2018/0192943 (“Annoni 2”).
Regarding Claims 1, 14, and 20, Annoni discloses a “compute” device, associated software provided on a computer readable medium, and method of its use to manage patient pain, comprising:
Providing computer-readable storage media comprising a plurality of instructions which are executed by circuitry of the “compute” device (Par. 105) to:
Obtain patient state data indicative of a present state of a patient detected by one or more patient monitor devices, wherein the patient state data includes at least one of heart rate data indicative of a heart rate of the patient or respiration rate data indicative of a respiration rate of the patient (510);
Obtain patient medication data indicative of a schedule for administration of pain medication to the patient (Par. 72, 82, 83, 95);
Determine whether a trend in the patient state data satisfies a predefined condition (Par. 70, 78, 79);
Determine whether the patient medication data indicates that the patient is due for administration of pain medication within a predefined time period (Par. 82, 83, 95);
Determine, in response to a determination that the trend in the patient state data satisfies the predefined condition and a determination that the patient is due for administration of pain medication within the predefined time period, that the patient is experiencing pain (530 – Par. 65, 66, 79); and
Produce, in response to a determination that the patient is experiencing pain, an alert signal (Par. 83).
Annoni discloses the invention substantially as claimed except that the system also determines a measure of pain sensitivity of a patient using information from a stimulation process in which one or more stimuli are applied to the patient by a stimulation device and a corresponding patient response is detected. Annoni does make reference of “Patient-Specific Calibration of Pain Quantification” (Par. 2, 81), however it is not explicitly disclosed how Annoni particularly envisages using this incorporated documentation.
However, this incorporated disclosure points to Annoni 2 which discusses, in detail, patient-specific calibration of pain quantification and its utility in pain management. Specifically, Annoni 2 describes a stimulation device (450) which is supplied to provide stimuli to a patient in order to measure the patient response to the quantified stimuli and use that information to determine a baseline/calibrated pain sensitivity of the patient to stimuli (Par. 8, 68, 83, 84, 95-97; Fig. 6, 7) thereby creating a useful, personally tailored model to gauge an individual’s pain tolerance (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Annoni to determine a measure of pain sensitivity of a patient using information used in a stimulation process via induced stimuli which are used to measure a patient response to said induced stimuli, as disclosed by Annoni 2, in order to create a calibrated baseline model which accounts for a patient’s initial pain tolerance so that the system may more accurately reflect their individual needs.
Regarding Claims 2 and 15, Annoni discloses the circuitry administers, in response to a determination that the patient is experiencing pain, pain medication to the patient using a pain medication administration device (Par. 47).
Regarding Claims 3 and 16, Annoni discloses producing the alert signal may comprise producing an audible alert, an alert on a screen, a nurse call signal, or a message to a caregiver mobile device (Par. 46, 70, 83).
Regarding Claims 7, Annoni discloses the invention substantially as claimed except that a predefined condition is determined via a measured increase in respiration rate of the patient by five breaths per minute OR 30% in less than three hours.
However, Annoni does disclose that the system can monitor increases in respiration rate in order to determine that the patient is experiencing a physical condition indicative of a pain response (Par. 42) and that consideration of the rate change of these metrics as well as their absolute changes should be used to determine the onset of pain (Par. 78) such that corrective action can be taken. As such, the ordinary artisan would clearly recognize and appreciate that the increase in respiration rate (both as a rate percent and an absolute value of breaths per minute) constitutes a result effective variable for correlating a change in measurable physiological data with thresholds indicative of the presence of pain.
However, it is submitted that, given respiration rate (and increases thereto) being a result effective variable (see Par. 42 and 78 of Annoni), it would have been obvious for the ordinary artisan to set suitable thresholds (or threshold ranges) in the practice of the methods such that the measured values for these parameters correlate to the physiological response of any individual patient OR groups of patients to thereby maximize efficacy using empirically derived data. The claimed changes (RE: 5 breaths per minute and/or a 30% increase within three hours) constitute an obvious, inevitable result of the ordinary artisan discovering the optimal or workable range for any particular patient (or population of patients). It has been determined that discovering the optimal or workable range of a result effective variable requires only routine and customary skill in the art and is obvious when only expected and predictable results are obtained, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here only the expected results of discovering the EXACT respiration rate increase (either in absolute terms or as a rate change) which is necessary to quantify the already identified relationship between breathing increase pursuant to pain onset would be determined. It has been held that only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions, see In re Williams, 36 F.2d 436, 438 (CCPA 1929).
Regarding Claim 8, Annoni discloses the invention substantially as claimed except that the system determines a trend wherein the patient’s heart rate has increased by 15 beats per minute or 30% in less than three hours.
However, like respiration rate, Annoni also recognizes that increases in heart rate (both as an absolute and a rate change) correlate to the presence of a pain response (see Par. 42 and 78) and that these changes can be used to determine that the patient is likely experiencing pain. While Annoni does not particularly quantify the increase to be a threshold of 15bpm OR a 30% increase within three hours, such determinations are held to constitute mere result effective variables incident to the relationship already recognized by Annoni. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to set the threshold for pain determination to be an increase of 15bpm or 30% in less than three hours as a product of routine and customary experimentation and optimization to discover the optimal or workable range for any particular patient or population of patients.
It has been determined that discovering the optimal or workable range of a result effective variable requires only routine and customary skill in the art and is obvious when only expected and predictable results are obtained, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here only the expected results of discovering the EXACT heart rate increase (either in absolute terms or as a rate change) which is necessary to quantify the already identified relationship between heart rate increase pursuant to pain onset would be determined. It has been held that only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions, see In re Williams, 36 F.2d 436, 438 (CCPA 1929).
Regarding Claim 9, Annoni provides for continuous monitoring of the patient’s physiological responses incident to drug delivery and the onset of pain symptoms such that determinations will be made whether the patient is due for administration of medicament at any time – inclusive to periods of 15 minutes.
Regarding Claim 10, Annoni discloses the circuitry is further configured to: obtain patient state data indicative of movement of the patient (Par. 57) and monitor for determination that the patient movement has increased. However, Annoni discloses the invention substantially as claimed except that that the trend is determined to satisfy the predetermined condition when the respiration rate of the patient has increased by five breaths per minute or 30% in less than three hours AND/OR when the heart rate has increased by 15 beats per minute or 30% in less than three hours.
However, as discussed further above, the invention of Annoni correlates the changes in this physiological data with the onset of pain and discusses using this information to make determinations as to whether the patient is likely experiencing pain. As such, the movement data, heart rate data, and respiratory rate data each constitute established result effective variables noted by Annoni to be useful for identifying pain state based upon the changes thereof. As such, the instantly claimed ranges present only inevitable conclusions as to discovering the optimal or workable ranges which might be useful for any particular patient or populations of patients and would have been discovered by the ordinary artisan during routine and customary experimental testing to reduce the invention to actual practice in situ.
Therefore, it would have been obvious for one having ordinary skill in the art at the time the invention was made to adapt the trend analysis of Annoni for respiration rate and heart rate to, respectively, determine the predefined condition has been satisfied when the respiration rate of the patient has increased by five breaths per minute or 30% in less than three hours and/or the heart rate of the patient has increased by 15 beats per minute or 30% in less than three hours in order to optimize the recognize result effective variable for the workable range over which it will be effective for diagnosing patient pain.
It has been determined that discovering the optimal or workable range of a result effective variable requires only routine and customary skill in the art and is obvious when only expected and predictable results are obtained, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 12, Annoni disclose that the system may measurement movement of the patient using a wearable set of load cells (Par. 57).
Regarding Claim 13, Annoni discloses obtaining heart rate variability data indicative of lengths of time between heart beats of the patient (i.e. determination of heart rate necessarily determines the time between heart beats as a product of time dependent frequency).
Claim(s) 4-6, 11, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0192941 (“Annoni”) in view of U.S. Publication No. 2018/0192943 (“Annoni 2”) as applied above, and further in view of U.S. Publication No. 2007/0118054 (“Pinhas”).
Regarding Claim 4, 5, 17, 18, Annoni discloses the invention substantially as claimed except that that the circuitry:
determines a pain medication administration time indicative of when the patient was last administered pain medication;
determines a decline in the respiration rate of the patient over a predefined time period after the pain medication administration time; and
Determines whether the decline satisfies a reference decline indicative of opioid induced respiratory distress.
Specifically, while Annoni does monitor the scheduled delivery of medicaments and the change in respiratory rates over time, Annoni fails to explicitly suggest examining the respiratory rates to determine whether a decline in respiration is incident to the previous administration of pain medication in order to make a determination that the decline is indicative of an opioid induced respiratory distress incident to the prior drug delivery. However, Pinhas discloses a system which coordinates the scheduled delivery of medications with the monitoring of the receiving patients in order to check for clinical episodes incident to the delivery of the medication (Abstract). Among the clinical episodes the system is configured to monitor for include respiratory distress/decline incident to the delivery of pain medications such as opioids (Abstract; Par. 238, 315, 318, 338, 424) and generate warnings to alert a clinician about respiratory distress incident to the drug delivery.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Annoni to coordinate respiratory monitoring with the scheduled/programmed drug delivery in order to monitor changes in respiratory rate incident to the drug delivery and monitor for adverse effects thereto incident to respiratory depression, as disclosed by Pinhas, in order to generate alerts to a clinician and allow for intervention to occur should it be determined that the patient is experiencing adverse side effects incident to the prior delivery of the pain medicaments inclusive to opioids.
Regarding Claims 6 and 19, Annoni, as modified, discloses the invention substantially as claimed except that reference decline is determined based on the respiration rate having decreased by at least five breaths per minute or 30% of an initial respiration rate within a period of four hours after the pain medication administration time. However, as discussed in greater detail above it must be understood, based on the combined disclosures of Annoni and Pinhas, that the change in respiration rate decline is a result effective variable and therefore optimization through routine experimentation to determine the optimal or workable threshold for any particular patient or patient group is obvious in order to determine the physiological data point which is most useful to serve as the threshold limit, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of modified Annoni to warn of respiratory distress based on the respiration rate having decreased by at least five breaths per minute or 30% of an initial respiration rate within a period of four hours after the pain medication administration time, thereby achieving only the expected and predictable results of implementing the workable or optimized range for coordinating the observe rate of decrease of respiration incident to drug delivery in order to prevent harm to the patient.
Regarding Claims 11, Annoni discloses the invention substantially as claimed except that that the movement data includes BOTH movement frequency data AND movement magnitude data. Rather, Annoni only suggests tying movement to respiration rate and therefore is understood to examine only frequency data. However, Pinhas discloses that monitoring of respiration can include analyzing the depth/magnitude of respiration movements (Par. 189) in order to analyze patterns to monitor for clinical episodes. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Annoni to examine not only rate of respiration movements, but also depth, as disclosed by Pinhas, in order to coordinate BOTH frequency and magnitude changes with patient pain systems and incidence of respiratory distress to determine increases and decreases of significant clinical value.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 04/16/2026
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