Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Claims 2-21 are presented for examination. Assignee: Stryker Corp. PD: 17 July 2012
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2-7, and 13-17 are rejected under 35 USC 103 as being unpatenable over Collins, U.S. 2008/0094207.
On claim 2, Collins cites except as underlined:
A notification system comprising:
a healthcare system operable to receive information from a patient support, wherein the information obtained from the patient support is indicative of a characteristic associated with the patient;
[0050] Screen 50 includes a name block 52 in which the patient's name is entered and a notes block in which additional notes about the patient or the patient's condition may be entered as shown in FIG. 3. Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained (i.e., that the patient is confined to bed 10 or that the patient is not to leave bed 10 without an alarm).
the healthcare system configured to assign a criterion to a patient supported on the patient support, wherein a monitoring system automatically associates the criterion with a monitored condition,
See above, Restrained check box 56 associated with patient with fall risk.
wherein the criterion is automatically generated by a system remote from the patient support;
As above and figure 7 (showing Nurse Call Module): Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained
[0055] In the illustrative example, the Head Angle subcategory under the Patient Safety category is selected. Screen 65 has an Enable Event Notification check box 78 that is selected (e.g., checked) if the user wants to have the system generate an alarm when a head angle (e.g., angle of articulation of a head section of bed 10) meets or exceeds a threshold value.
and
the healthcare system operable to generate a notification to a caregiver when information obtained from the patient support is indicative of a deviation relative to the criterion associated with the patient.
[0113] One or more of devices 310 includes software that permits caregivers to program alarm conditions (sometimes referred to herein as "boundary conditions") for not only beds 314 but also for one or more of the pieces of equipment 316, 318 coupled to network 312. Such programming of the alarm conditions using devices 310 is substantially similar to the programming that occurs using Care Alert templates as described above. In some embodiments, the alarm conditions for beds 314 and equipment 316, 318 are programmable using a single PC 310 which may be located at a Master Nurse Call Station as part of a nurse call system of network 312. Care Alert templates for equipment 316, 318 may be configured in accordance with Standards of Care (SOC's) in a manner similar to the manner in which Care Alert templates for beds are configured as described above.
Regarding the excepted: wherein the criterion is automatically generated,” as disclosed above, Collins discloses a user’s option to enable fall risk check box 54 and restrained check box 56. Collins doesn’t disclose where the criterion is automatically generated. However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to include into Collins the ability for the system to enable criterion via a manual means. While Collins doesn’t specifically disclose enabling the above check boxes in an automatic manner, unless the automation of the selection of the check boxes provides something new or unexpected over manual selection, merely making automatic an otherwise manual activity isn’t patentable subject matter:
MPEP 2144.04
III. AUTOMATING A MANUAL ACTIVITY
In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined "old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed." The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.).
Regarding the excepted: wherein the criterion is automatically generated by a system remote from the patient support, Figure 7 discloses a nurse call module used to monitor and control event notifications for a patient’s’ bed 38. Collins doesn’t specifically disclose the nurse call station being remote from the patient support. However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the nurse call station disclosed in Collins to remotely control the event notifications regarding the cited patent bed. One of ordinary skill would have included such a feature the convenience of remotely programming the patient notification system without having to personally go to the patient’s bed.
On claim 3, Collins cites;
The notification system of claim 2, wherein the monitored condition is based on the information received from the patient support, and wherein the deviation relative to the criterion is based on a comparison between the monitored condition and the criterion.
[0050] Screen 50 includes a name block 52 in which the patient's name is entered and a notes block in which additional notes about the patient or the patient's condition may be entered as shown in FIG. 3. Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained (i.e., that the patient is confined to bed 10 or that the patient is not to leave bed 10 without an alarm).
(In this case, the patient is to be restrained. Any attempts to remove the restraint is responded to with an alarm)
On claim 4, Collins cites:
The notification system of claim 2, wherein the healthcare system is configured to
enable manual adjustment of the criterion.
[0050] Screen 50 includes a name block 52 in which the patient's name is entered and a notes block in which additional notes about the patient or the patient's condition may be entered as shown in FIG. 3. Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained (i.e., that the patient is confined to bed 10 or that the patient is not to leave bed 10 without an alarm).
(In this case, the “manual adjustment” would be the caregiver’s manipulation of the check boxes).
On claim 5, Collins cites: The notification system of claim 2, wherein the information corresponds to at least one of a configuration of the patient support and sensor information pertaining to the patient.
[0050] Screen 50 includes a name block 52 in which the patient's name is entered and a notes block in which additional notes about the patient or the patient's condition may be entered as shown in FIG. 3. Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained (i.e., that the patient is confined to bed 10 or that the patient is not to leave bed 10 without an alarm).
(The configuration is the restraint check box and the sensor information is the patient leaving the bed without the restraint).
On claim 6, Collins cites:
The notification system according to claim 2, wherein the healthcare system also
includes room information of the patient support. Figure 5, item 50, patient-room 413.
On claim 7, Collins cites:
The notification system according to claim 2, wherein the healthcare system is
configured to generate multiple notification levels when the healthcare system detects the monitored condition deviates from the criterion associated with the patient.
[0050] Screen 50 includes a name block 52 in which the patient's name is entered and a notes block in which additional notes about the patient or the patient's condition may be entered as shown in FIG. 3. Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained (i.e., that the patient is confined to bed 10 or that the patient is not to leave bed 10 without an alarm).
(the notification levels include the fall risk and restraint alarm).
On claim 13, Collins cites;
A notification system comprising:
a healthcare system, the healthcare system having a network and a server in communication with the network;
the healthcare system operable to receive information from a patient support, wherein the information is indicative of a current configuration of the patient support;
the healthcare system configured to associate a patient support configuration with a patient supported on the patient support, wherein the patient support configuration is automatically generated remotely from the patient support; and
the healthcare system configured to compare the current configuration of the patient support to the patient support configuration associated with the patient and to generate a notification to a caregiver when the current configuration of the patient support deviates from the patient support configuration associated with the patient. See the rejection of claim 2 which discloses the same subject matter as claim 13 and is rejected for the same reasons.
On claim 14, Collins cites except as underlined:
The notification system according to claim 13, wherein the server includes a
collection of data, and wherein the server is configured to automatically generate the patient support configuration based on the collection of data.
Collins cites:
[0050] Screen 50 includes a name block 52 in which the patient's name is entered and a notes block in which additional notes about the patient or the patient's condition may be entered as shown in FIG. 3. Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained (i.e., that the patient is confined to bed 10 or that the patient is not to leave bed 10 without an alarm).
Collins, in the above passage, is disclosing that a user is checking the check boxes, the implication is that the user, and not a server, is generating patient support configurations. Furthermore, checking the checkbox is a manual and not an automatic feature.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to include into Collins the added feature of generating patient support configurations. A server is merely collecting data to generate a patient support configuration, which is no different from a caregiver, also in possession of that same type information, to carry out doing the patient support configuration in the check boxes disclosed in Collins. Unless the use of a server provides something new or unexpected and the reference otherwise carries out the claimed invention, claiming the server as generating the patient support configuration isn’t considered patentable subject matter.
Regarding the “automatically generate” nature of the invention, unless the automation of the selection of the check boxes provides something new or unexpected over manual selection, merely making automatic an otherwise manual activity isn’t patentable subject matter:
MPEP 2144.04
III. AUTOMATING A MANUAL ACTIVITY
In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined "old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed." The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.).
On claim 15, Collins cites;
The notification system according to claim 13, wherein the healthcare system is
configured to enable manual adjustment of the patient support configuration.
[0050] Screen 50 includes a name block 52 in which the patient's name is entered and a notes block in which additional notes about the patient or the patient's condition may be entered as shown in FIG. 3. Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained (i.e., that the patient is confined to bed 10 or that the patient is not to leave bed 10 without an alarm).
On claim 16, Collins cites:
The notification system according to claim 13, wherein the healthcare system also includes room information of the patient support. Figure 5, item 50, patient-room 413.
On claim 17, Collins cites:
The notification system according to claim 13, wherein the healthcare system is
configured to generate multiple notification levels when the healthcare system determines that the current configuration deviates from the patient support configuration associated with the patient.
[0050] Screen 50 includes a name block 52 in which the patient's name is entered and a notes block in which additional notes about the patient or the patient's condition may be entered as shown in FIG. 3. Screen 50 also includes a Fall Risk check box 54 that is checked to indicate that the patient has a risk of falling and a Restrained check box 56 that is checked to indicate that the patient is restrained (i.e., that the patient is confined to bed 10 or that the patient is not to leave bed 10 without an alarm).
(the notification levels include the fall risk and restraint alarm).
Claim 10-12, 20, and 21 are rejected under 35 USC 103 as being unpatenable over Collins, U.S. 2008/0094207 in view of Al-Ali, U.S. 2003/0137423.
On claim 10, Collins cites except as underlined:
The notification system according to claim 2, further comprising a physiological
sensor to sense a physiological condition of the patient supported on the patient support, wherein the healthcare system receives information about the physiological condition of the patient based on sensor output from the physiological sensor, and wherein the healthcare system is configured to process the information received from the physiological sensor to determine whether a healthcare worker should be notified of an event.
Collins cites:
[0112] Examples of monitoring equipment 316 which communicate data to devices 310 include, for example, blood pressure measuring devices, respiration rate measuring devices, temperature measuring devices, pulse oximeters, electrocardiograms (EKG's), and electroencephalograms (EEG's). As contemplated by this disclosure, equipment 316 includes equipment of all types that measure patient physiological conditions.
Collins doesn’t cite the excepted claim limitations. In the same at of patient monitoring, Al-Ali cites:
[0002] Physiological measurement instruments employed in healthcare environments often feature visual and audible alarm mechanisms that alert a caregiver when a patient's vital signs are outside of predetermined limits. One example is a pulse oximeter, which measures the oxygen saturation level of arterial blood, an indicator of oxygen supply. A typical pulse oximeter displays a numerical readout of the patient's oxygen saturation, a numerical readout of pulse rate, and a plethysmograph, which is indicative of a patient's pulse. In addition, a pulse oximeter provides an alarm that warns of a potential desaturation event.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify Collin’s patient monitoring system using the features disclosed in Al-Ali such that the claimed invention is realized. Al-Ali discloses a known process of providing an alarm for a patient’s monitored physiology and one of ordinary skill would have provided the alarm feature for out of the ordinary readings as is known in the art.
On claim 11, Collins and Al-Ali cites:
The notification system according to claim 10, wherein the healthcare system
generates an alert in the event that a change to a physiological condition of a patient, as detected by the physiological sensor, varies a threshold amount from a default setting for the physiological condition. See the rejection of claim 10 citing Al-Ali [0002].
On claim 12, Collins cites:
The notification system according to claim 2, wherein the healthcare system stores documentation regarding the monitored condition.
[0140] The data received from beds 10, 159, 314, 342, 362, 364 by the associated nurse call system (such as system 112) may be provided to other systems of the hospital network. In one example, beds 10, 159, 314, 342, 362, 364 having weigh scale systems transmit patient weight to system 112 which, in turn, transmits the patient weight data to an electronic medical records (EMR) system (such as system 18) which, in turn, stores the weight information in the associated patient's record. The nurse call system 112 may convert the data from one communication protocol into another communication protocol. Thus, patient weight data received by system 112 may be converted by system 112 into the Health Level 7 (HL7) protocol for transmission to the EMR system.
On claim 20, Collins and Al-Ali cites
The notification system according to claim 13, further comprising a physiological
sensor to sense a physiological condition of the patient supported on the patient support, wherein the healthcare system receives information about the physiological condition of the patient based on sensor output from the physiological sensor, and wherein the healthcare system is configured to process the information received from the physiological sensor to determine whether a healthcare worker should be notified of an event. See the rejection of claim 10 which discloses the same subject matter as claim 20 and is rejected for the same reasons.
On claim 21, Collins cites: The notification system according to claim 20, wherein the healthcare system stores documentation regarding the sensed physiological condition of the patient.
[0140] The data received from beds 10, 159, 314, 342, 362, 364 by the associated nurse call system (such as system 112) may be provided to other systems of the hospital network. In one example, beds 10, 159, 314, 342, 362, 364 having weigh scale systems transmit patient weight to system 112 which, in turn, transmits the patient weight data to an electronic medical records (EMR) system (such as system 18) which, in turn, stores the weight information in the associated patient's record. The nurse call system 112 may convert the data from one communication protocol into another communication protocol. Thus, patient weight data received by system 112 may be converted by system 112 into the Health Level 7 (HL7) protocol for transmission to the EMR system.
Claims 8 and 18 are rejected under 35 USC 103 as being unpatenable over Collins, U.S. 2008/0094207 in view of Warner U.S. 2010/0082363.
On claim 8, Collins cites except as underlined:
The notification system according to claim 2, wherein the healthcare system is
configured to detect when a configuration of the patient support is modified or corrected to meet the criterion associated with the patient.
Collins cites:
[0112] Examples of monitoring equipment 316 which communicate data to devices 310 include, for example, blood pressure measuring devices, respiration rate measuring devices, temperature measuring devices, pulse oximeters, electrocardiograms (EKG's), and electroencephalograms (EEG's). As contemplated by this disclosure, equipment 316 includes equipment of all types that measure patient physiological conditions.
Collins doesn’t disclose the excepted claim limitations. In the same art of patient monitoring, Warner cites:
[0047] In response to updating and comparing the health risk directed to one patient 115 in response to tracking changes in comparison to thresholds of step 295, changes to biometric data, changes to wait times, etc., step 298 can include changing the priority of the protocol 212, including tests or procedures or scheduling of resources 105 (e.g., physicians, surgeons, staff, surgery or other procedural or examination rooms, equipment such as imaging systems, etc.) relative to scheduling of resources 105 directed to other patients 115.
(In short, Warner discloses an embodiment in which is directed to changing a priority of protocols responsive to updating and comparing health risks to a patient).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the Collin’s patient configuration support using the features disclosed in Warner such that the claimed invention is realized. Warner discloses a known embodiment for determining updates and changes to a patient support system, changes that are responsive to a patient’s health condition. One of ordinary skill would have included this feature to track the changes in health of a patient and the responsiveness of the patient support system in adapting to these changes.
On claim 18, Collins and Warner cites:
The notification system according to claim 13, wherein the healthcare system is
configured to determine when the current configuration of the patient support is modified or corrected to meet the patient support configuration associated with the patient.
See the rejection of claim 8 which discloses the same subject matter as claim 18 and is rejected for the same reasons.
Claim 9 and 19 are rejected under 35 USC 103 as being unpatenable over Collins, U.S. 2008/0094207 in view of Warner U.S. 2010/0082363 and Ziegler, U.S. 2011/0106200.
On claim 9, Warner cites except as underlined:
The notification system according to claim 8, wherein the healthcare system is configured to either cancel the notification or send another notification indicating that the patient is no longer at risk.
Warner cites:
[0047] In response to updating and comparing the health risk directed to one patient 115 in response to tracking changes in comparison to thresholds of step 295, changes to biometric data, changes to wait times, etc., step 298 can include changing the priority of the protocol 212, including tests or procedures or scheduling of resources 105 (e.g., physicians, surgeons, staff, surgery or other procedural or examination rooms, equipment such as imaging systems, etc.) relative to scheduling of resources 105 directed to other patients 115.
Neither Collins nor Warner discloses the excepted claim limitations. In the same art of patient monitoring, Ziegler cites:
[0026] In some examples, the stroke risk monitoring system may be configured to alert a user, e.g., a clinician and/or patient, based on the stroke risk score generated by the system. For example, the stroke risk monitoring system may alert a user when the stroke risk score computed by the stroke risk monitoring system reaches some preset threshold value. In other examples, the stroke risk monitoring system may alert a user upon a change to the stroke risk score computed by the monitoring system (e.g., any increase or decrease in the stroke risk score). In this manner, using an IMD to monitor one or more physiological parameters of a patient, the stroke risk monitoring system may track the stroke risk of a patient, and alert a user to increased, decreased and/or untenable stroke risk developed by a patient. By monitoring the stroke risk of the patient using such a monitoring system, the development of a relatively high stroke risk may be identified within a relatively short period of time and, thus, may be addressed in a timely manner, e.g., via the prescription of anticoagulants by a clinician. Similarly, a reduction in the stroke risk of a patient may be identified within a relatively short period of time and, thus, may be addressed in a timely manner, e.g., by terminating or adjusting the prescription of anticoagulants to the patient to be consistent with the reduced stroke risk.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify Collins and Warner using the embodiment disclosed in Ziegler such that the claimed invention is realized. Ziegler discloses a known embodiment in which patient risk is reduced as a result of an adjusting in medical procedures. Accordingly, in the event of the change of the medications prescribed to a patient, medical risk is commensurately reduced. Accordingly, the claimed limitations are satisfied since there is a reduction in risked due to a determined change in medical practices responsive to an improved health outlook of the patient.
One of ordinary skill, apprised in the change of the patient’s condition, would have including a change in risk notification to reflect the changing health of the patient.
On claim 19, Collins, Warner, and Ziegler cites:
The notification system according to claim 18, wherein the healthcare system is
configured to either cancel the notification or send another notification indicating that the patient is no longer at risk. See the rejection of claim 9 which discloses the same subject matter as claim 19 and is rejected for the same reasons.
Conclusion
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 extension fee 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 CAL EUSTAQUIO whose telephone number is (571)270-7229. The examiner can normally be reached on 8am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Nabil Syed, can be reached at (571) 272-2963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http:/lpair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-91 99 (IN USA OR CANADA) or 571-272-1000.
/CAL J EUSTAQUIO/Examiner, Art Unit 2686
/BRIAN A ZIMMERMAN/Supervisory Patent Examiner, Art Unit 2686
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