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 .
Drawings
The drawings are objected to because reference character “34” appears to be partially obscured in Fig. 1.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “28” appears to designate different structural elements of the hospital bed in Fig. 1
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “26” [Applicant’s Specification ¶0059].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “80” [Fig. 1]; “412” [Fig. 11].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Applicant’s Specification ¶0059 recites “an articulated seat deck 30 (Seen in Fig. 3)… a fixed seat deck 32 (also seen in Fig. 3)”, wherein the Examiner notes that neither of the articulated seat deck 30 nor fixed seat deck 32 are depicted in Fig. 3 [The Examiner notes that both the articulated seat deck 30 and fixed seat deck 32 appear in Applicant’s Fig. 2].
Appropriate correction is required.
Claim Objections
Claim(s) 1, 9, 11-12 and 14-16 is/are objected to because of the following informalities:
Claims 1 and 9 appear to use “temperature monitor” and “temperature system” interchangeably. Each instance of “temperature monitor” and “temperature system” should read only one or the other of “temperature monitor” or “temperature system”.
Claims 11-12 and 14-16 appear to use “temperature monitor” and “temperature system” interchangeably. Each instance of “temperature monitor” and “temperature system” should read only one or the other of “temperature monitor” or “temperature system”.
Claim 11 should read “[[the]] a core temperature” [line 6].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1, 9, 11, 14-16, and those dependent therefrom rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “utilizing data from the cardiopulmonary monitor and the patient’s body temperature to establish an early warning score for the patient” [lines 10-11], which is considered indefinite, as it is not clear what element of the patient support apparatus is meant to perform the function of the recited limitation. Furthermore, as there is no clear link between any particular element of the patient support apparatus being configured to perform the claimed function of the recited limitation, the recited limitation is considered to define a method step in an apparatus claim [A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011) (MPEP §2173.05(p)(II))]. For examination purposes, the Examiner has interpreted any structure(s)/element(s) that may comprise at least a portion of a patient support apparatus that is capable of performing the function of the recited limitation of claim 1 as reading on the patient support apparatus as claimed under any § 102 or § 103 rejection.
Claim 1 recites the limitation “the diagnostic system comparing the early warning score for the patient to a threshold early warning score indicative of an imminent adverse event, and, if the early warning score exceeds the threshold, providing an output to initiate a therapeutic intervention to address the patient’s condition” [lines 11-15] and claim 9 recites the limitation “the diagnostic system identifies the position of the movable portion of the patient support apparatus to determine if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient” [lines 2-5], wherein each recited limitation is considered indefinite, as the “diagnostic system” in each of claims 1 and 9 is considered to comprise a plurality of elements, such that it is not clear which element of the plurality of elements that comprise the “diagnostic system” is meant to perform the claimed functions in each of claims 1 and 9 [see emphasized portions of claims 1 and 9]. For examination purposes, the Examiner has interpreted any structure(s)/element(s) that may comprise at least a portion of a diagnostic system that is capable of performing the claimed functions of claims 1 and 9 as reading on the diagnostic system as claimed under any § 102 or § 103 rejection.
Claim 9 recites the limitation “a location of a feature of the patient” [line 5], which is considered indefinite, as it is not clear whether the recited location and feature of the patient of claim 9 is meant to be a different location and a different feature from the location of the feature as recited in claim 1 [lines 6-7] or not. For examination purposes, the Examiner has interpreted at least the feature of claim 9 to be the same as the feature of claim 1 under any § 102 or § 103 rejection.
Claim 11 recites the limitation “the diagnostic system determining an early warning score of the patient in real-time” [line 7], claim 15 recites the limitation “the diagnostic system identifies the position of the movable portion of the patient support apparatus to determine if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient” [lines 2-5], and claim 16 recites the limitation “the diagnostic system determines if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient” [lines 1-3], wherein each recited limitation is considered indefinite, as the “diagnostic system” in each of claims 11 and 15-16 is considered to comprise a plurality of elements, such that it is not clear which element of the plurality of elements that comprise the “diagnostic system” is meant to perform the claimed functions in each of claims 11 and 15-16 [see emphasized portions of claims 1 and 9]. For examination purposes, the Examiner has interpreted any structure(s)/element(s) that may comprise at least a portion of a diagnostic system that is capable of performing the claimed functions of claims 11 and 15-16 as reading on the diagnostic system as claimed under any § 102 or § 103 rejection.
Claim 14 recites the limitations “the targeting sensor” [line 1] and “the infrared sensor” [line 3], which are each considered to lack antecedent basis, as claims 11 and 14 fail to previously define “a targeting sensor” or “an infrared sensor”. The recited limitations of claim 14 are further considered to render claim 14 indefinite, as it is unclear whether claim 14 is meant to be dependent from any of claims 12-13, which do define a targeting sensor and an infrared sensor, which would provide antecedent basis to the targeting sensor and the infrared sensor of claim 14. For examination purposes, the Examiner has interpreted claim 14 to be dependent from claim 13.
Claim 15 recites “a feature of the patient” [line 5] and claim 16 recites “a feature of the patient” [line 3], which are each considered indefinite, as it is not clear whether the recited feature of the patient of each of claims 15-16 is/are meant to be a different feature from the feature as recited in claim 14 [line 2] or not. For examination purposes, the Examiner has interpreted the feature of claims 15-16 to be the same as the feature of claim 14 under any § 102 or § 103 rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 11 and 17-19 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 9 of U.S. Patent No. 8,525,680, hereinafter Riley ‘680 in Double Patenting section only, in view of Riley (US-20110068935-A1), hereinafter Riley ‘935 in Double Patenting section only.
Conflicting claim 9 of Riley ‘680 is considered to anticipate almost each and every limitation of instant claim 11 [see comparison below], except wherein the temperature monitor is positioned on a movable portion of the patient support, wherein the signal provided by the temperature monitor is a signal indicative of the core temperature of the patient, and wherein the early warning score is determined in real time.
Riley ‘935 discloses systems for providing an early warning score for a patient supported on a patient support apparatus, wherein Riley discloses positioning a temperature monitor configured to measure a core temperature of the patient on a movable portion of the patient support apparatus [the contact-less sensors 3046 include one or more of the following:… temperature sensors 3062 configured to sense the person's body temperature (Riley ‘935 ¶0043, Fig. 5); It should also be appreciated that, in some embodiments, the supports 3020 move the upper frame 3018 to a Trendelenburg/reverse Trendelenburg position and/or rotate the upper frame 3014 from side to side with respect to the lower frame 3012 (Riley ‘935 ¶0034); The sensors 3036 and/or the control modules 3038 are coupled to the upper frame 3018 in some embodiments. It should be appreciated that the sensors 3036 and/or the control modules 3038 can be coupled to the lower frame 3016, supports 3020, and/or incorporated within or coupled to the person support surface 3020 in other embodiments, if desired (Riley ‘935 ¶0039); In some embodiments, the contact-less sensors 3046 are coupled to at least one of the upper frame 3018, the supports 3020, and/or the lower frame 3016. It should be appreciated that the contact-less sensors 3046 can be coupled to the casters 3024 and/or engaged by the casters 3024, if desired (Riley ‘935 ¶0041)]. Riley ‘935 further discloses determining the early warning score in real-time [sensors 3036 post data signals substantially continuously and, in other embodiments, sensors 3036 post data signals at predetermined intervals. The data signals from sensors 3036 are representative of heart rate, respiration rate, temperature, blood pressure and/or SpO2 as indicated at block 3082 of FIG. 6 (Riley ‘935 ¶0053); In the operation of block 3088, the controller 3074 executes the algorithm to generate a condition score corresponding to the condition of the person and/or to generate a graphic representative of the condition of the person. In one embodiment, the algorithm receives inputs from the contact-less sensors 3046 corresponding to the heart rate, respiration rate, and temperature of a person, and inputs from the contact sensors 3044 corresponding to the blood pressure and SpO2 of a person (Riley ‘935 ¶0056); In another contemplated embodiment, the condition score comprises a modified early warning score (MEWS). According to this disclosure, the data needed to calculate the MEWS is obtained from sensors included as part of person support apparatus 3014, obtained via manual user inputs, obtained from separate monitoring equipment that communicates with controller 3074 of apparatus 3014, and/or obtained from the person's EMR. The MEWS is a known score calculated based on the following table… In the MEWS table, the various integers in the column headings are added together based on the various readings for the person of the data corresponding to the rows of the table. A score of 5 or greater indicates a likelihood of death. With regard to the systolic blood pressure, heart rate, respiratory rate, and temperature portions of the MEWS, those pieces of information are obtained using sensors 3036 of person support apparatus 3014 and/or using the other manners of obtaining a person's physiological data as discussed above (Riley ‘935 ¶¶0059-0060, Table 1), wherein continuous monitoring and diagnosis is considered to read on the claimed real-time analysis].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of conflicting claim 9 of Riley ‘680 to employ wherein the temperature monitor is positioned on a movable portion of the patient support, and wherein the signal provided by the temperature monitor is a signal indicative of the core temperature of the patient, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [positioning the temperature monitor at a location that is viable for monitoring temperature; determining the early warning score in real-time] [MPEP § 2143(I)(D)]; and as this modification would amount to mere simple substitution of one known element for another with similar expected results [temperature monitor of conflicting claim 9 of Riley ‘680 for measuring a person’s temperature for the temperature monitor of Riley ‘935 for measuring a person’s body temperature] [MPEP § 2143(I)(B)].
Conflicting claim 9 of Riley ‘680 as modified by Riley ‘935 is further considered to render obvious instant claims 17-19 [See Riley ‘935 ¶¶0039, 0041, 0072].
Claim 11 of the Instant Application
Claim 9 of Conflicting Patent No. 8,525,680, hereinafter Riley ‘680 [in Double Patenting section only], wherein claim 9 of Riley ‘680 incorporates the subject matter of claims 1-2 and 6 therein
An early warning score monitoring system for a patient supported on a patient support apparatus comprising
A person monitor system comprising a person support apparatus configured to support a person [Col 17:47-48]
the controller calculating a condition score [Col 17:56-57]
wherein the condition score comprises a modified early warning score (MEWS) [Col 18:13-14]
a diagnostic system including a contactless cardiopulmonary monitor providing signals indicative of the heart rate and the respiratory rate of the patient, and a temperature monitor positioned on a movable portion of the patient support apparatus, the temperature monitor providing a signal indicative of the core temperature of the patient, the diagnostic system determining an early warning score of the patient in real-time, and
a second sensor sensing second information corresponding to a physiological characteristic of the person [Col 17:52-53]
wherein the second sensor comprises a plurality of sensors sensing the person’s… heart rate, respiration rate, and temperature, each of which is used by the controller to calculate the MEWS [Col 18:33-37]
a controller receiving… the second information sensed by the second sensor, the controller calculating a condition score as a function of… the second information [Col 17:54-58]
the condition score being a single quantitative or qualitative value related to the person’s health and from which a prediction of an onset of an adverse event is able to be predicted [Col 17:62-65]
a notification system providing a notification to a caregiver if the real-time early warning score exceeds a predetermined threshold.
a communication system coupled to the controller, the communication system alerting a caregiver in response to the condition score violating a predetermined threshold condition [Col 17:59-62]
Claim(s) 11 and 17-19 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 27 of U.S. Patent No. 11,504,071, hereinafter Terry ‘071 in Double Patenting section only, in view of Riley (US-20110068935-A1), hereinafter Riley ‘935 in Double Patenting section only.
Conflicting claim 27 of Terry ‘071 is considered to anticipate almost each and every limitation of instant claim 11 [see comparison below], except wherein the system is for a patient supported on the patient support apparatus, wherein the temperature monitor is positioned on a movable portion of the patient support, wherein the signal provided by the temperature monitor is a signal indicative of the core temperature of the patient, and wherein the notification is provided to the caregiver if the real-time early warning score exceeds a predetermined threshold.
Riley ‘935 discloses systems for providing an early warning score for a patient supported on a patient support apparatus [a person monitor system may comprise a person support apparatus supporting a person, the person support apparatus having a sensor that senses information regarding at least one of a change in position, a heart rate, and a respiration rate of the person on the person support apparatus (Riley ‘935 ¶0013)], wherein Riley discloses positioning a temperature monitor configured to measure a core temperature of the patient on a movable portion of the patient support apparatus [the contact-less sensors 3046 include one or more of the following:… temperature sensors 3062 configured to sense the person's body temperature (Riley ‘935 ¶0043, Fig. 5); It should also be appreciated that, in some embodiments, the supports 3020 move the upper frame 3018 to a Trendelenburg/reverse Trendelenburg position and/or rotate the upper frame 3014 from side to side with respect to the lower frame 3012 (Riley ‘935 ¶0034); The sensors 3036 and/or the control modules 3038 are coupled to the upper frame 3018 in some embodiments. It should be appreciated that the sensors 3036 and/or the control modules 3038 can be coupled to the lower frame 3016, supports 3020, and/or incorporated within or coupled to the person support surface 3020 in other embodiments, if desired (Riley ‘935 ¶0039); In some embodiments, the contact-less sensors 3046 are coupled to at least one of the upper frame 3018, the supports 3020, and/or the lower frame 3016. It should be appreciated that the contact-less sensors 3046 can be coupled to the casters 3024 and/or engaged by the casters 3024, if desired (Riley ‘935 ¶0041)]. Riley ‘935 further discloses wherein the notification is provided to the caregiver if the real-time early warning score exceeds a predetermined threshold [In the conditional of block 3100, if the controller 3074 determines that the condition score is greater than the threshold, then, in one illustrative embodiment, a status update including the condition score is communicated to a caregiver through the signaling and communication system 3012 and/or is displayed on the display 3040 as indicated at block 3110. That is, if the condition score exceeds the threshold, then, in some embodiments, at least one of the condition score and an alert signal are communicated to a caregiver (Riley ¶0066)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of conflicting claim 27 of Terry ‘071 to employ wherein the system is for a patient supported on the patient support apparatus, wherein the temperature monitor is positioned on a movable portion of the patient support, wherein the signal provided by the temperature monitor is a signal indicative of the core temperature of the patient, and wherein the notification is provided to the caregiver if the real-time early warning score exceeds a predetermined threshold, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [apply the patient monitoring to a patient that is supported on the patient support apparatus; positioning the temperature monitor at a location that is viable for monitoring temperature; provide a notification in response to a threshold being exceeded] [MPEP § 2143(I)(D)]; and as this modification would amount to mere simple substitution of one known element for another with similar expected results [temperature monitor of conflicting claim 27 of Terry ‘071 (thermometer) for the temperature monitor of Riley ‘935 for measuring a person’s body temperature] [MPEP § 2143(I)(B)].
Conflicting claim 27 of Terry ‘071 as modified by Riley ‘935 is further considered to render obvious instant claims 17-19 [See Riley ‘935 ¶¶0039, 0041, 0072].
Claim 11 of the Instant Application
Claim 27 of Conflicting Patent No. 11,504,071, hereinafter Terry ‘071, wherein claim 27 of Terry ‘071 incorporates the subject matter of claim 1 therein
An early warning score monitoring system for a patient supported on a patient support apparatus comprising
A system for use in a healthcare facility, the system comprising an analytics engine, a plurality of equipment providing data to the analytics engine, the data pertaining to a patient in the healthcare facility, the plurality of equipment including at least one of the following: a patient support apparatus [Col 80:54-60]
a diagnostic system including a contactless cardiopulmonary monitor providing signals indicative of the heart rate and the respiratory rate of the patient, and a temperature monitor positioned on a movable portion of the patient support apparatus, the temperature monitor providing a signal indicative of the core temperature of the patient, the diagnostic system determining an early warning score of the patient in real-time, and
a physiological monitor [Col 80:61]
the mobile device being configured to generate a screen on a display of the mobile device, the screen including: a first window having a scoring section that includes a modified early warning score (MEWS) calculated by the analytics engine and one or more vital signs that contribute to the calculation of the MEWS score [Col 81:32-38]
herein the plurality of equipment includes the physiological monitor and wherein the physiological monitor comprises at least one of the following: a wireless patch sensor attached to the patient, an ambulatory cardiac monitor, an EKG, a respiration rate monitor, a blood pressure monitor, a pulse oximeter, and a thermometer [Col 83:27-33]
[wherein the Examiner notes that data from an ambulatory cardiac monitor and/or an EKG is considered to be indicative of heart rate]
the analytics engine analyzes the data from the plurality of equipment to determine in substantially real time [Col 80:63-65]
a notification system providing a notification to a caregiver if the real-time early warning score exceeds a predetermined threshold.
a mobile device of a caregiver assigned to the patient and configured to receive wireless communications initiated by the analytics engine, the mobile device being configured to generate a screen on a display of the mobile device, the screen including: a first window having a scoring section that includes a modified early warning score (MEWS) calculated by the analytics engine and one or more vital signs that contribute to the calculation of the MEWS score… wherein the screen further includes respective arrow icons that appear adjacent the MEWS, the first score, and the second score to indicate whether the MEWS, the first score, and the second score, respectively, have increased or decreased from a prior reading [Col 81:30-38, 45-49]
Claim Analysis - 35 USC § 101
Examiner’s Note Regarding § 101 Analysis: The Examiner notes that claim(s) 1 and 11 recite(s) a judicial exception [“processing data from the targeting sensor to determine a location of a feature of a patient supported on the patient support apparatus”, “processing data from the infrared sensor in the location of the feature of the patient to determine the patient’s body temperature”, “utilizing data from the cardiopulmonary monitor and the patient’s body temperature to establish an early warning score for the patient”, “comparing the early warning score for the patient to a threshold warning score indicative of an imminent adverse event” in claim 1; “determining an early warning score of the patient in real-time” in claim 11] at Step 2A Prong 1, which is/are considered to be abstract idea(s) that may be performed in the mind or by hand by merely observing at least a limited amount of known or previously collected data or information and drawing mental conclusions therefrom based on known or derived relationships. However, the Examiner further notes that claim(s) 1 and 11 recites limitations that are directed towards additional element(s) [a patient support apparatus comprising the claimed combination of monitors/sensors of the diagnostic system and the particular location of the temperature monitor in claim 1; the claimed combination of monitors/sensors of the diagnostic system and the particular location of the temperature monitor on a patient support apparatus in claim 11] that is considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at Step 2B.
Claim Rejections - 35 USC § 102
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.
Claim(s) 11 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riley (US-20110068935-A1).
Regarding claim 11, Riley teaches
An early warning score monitoring system for a patient supported on a patient support apparatus comprising
a diagnostic system including a contactless cardiopulmonary monitor providing signals indicative of the heart rate and the respiratory rate of the patient [the contact-less sensors 3046 include one or more of the following:… heart rate sensors 3064 configured to sense the rate at which the person's heart contracts; respiration rate sensors 3066 configured to sense the person's breathing rate (Riley ¶0043, Fig. 5)], and a temperature monitor positioned on a movable portion of the patient support apparatus, the temperature monitor providing a signal indicative of the core temperature of the patient [the contact-less sensors 3046 include one or more of the following:… temperature sensors 3062 configured to sense the person's body temperature (Riley ¶0043, Fig. 5); It should also be appreciated that, in some embodiments, the supports 3020 move the upper frame 3018 to a Trendelenburg/reverse Trendelenburg position and/or rotate the upper frame 3014 from side to side with respect to the lower frame 3012 (Riley ¶0034); The sensors 3036 and/or the control modules 3038 are coupled to the upper frame 3018 in some embodiments. It should be appreciated that the sensors 3036 and/or the control modules 3038 can be coupled to the lower frame 3016, supports 3020, and/or incorporated within or coupled to the person support surface 3020 in other embodiments, if desired (Riley ¶0039); In some embodiments, the contact-less sensors 3046 are coupled to at least one of the upper frame 3018, the supports 3020, and/or the lower frame 3016. It should be appreciated that the contact-less sensors 3046 can be coupled to the casters 3024 and/or engaged by the casters 3024, if desired (Riley ¶0041)], the diagnostic system determining an early warning score of the patient in real-time [sensors 3036 post data signals substantially continuously and, in other embodiments, sensors 3036 post data signals at predetermined intervals. The data signals from sensors 3036 are representative of heart rate, respiration rate, temperature, blood pressure and/or SpO2 as indicated at block 3082 of FIG. 6 (Riley ¶0053); In the operation of block 3088, the controller 3074 executes the algorithm to generate a condition score corresponding to the condition of the person and/or to generate a graphic representative of the condition of the person. In one embodiment, the algorithm receives inputs from the contact-less sensors 3046 corresponding to the heart rate, respiration rate, and temperature of a person, and inputs from the contact sensors 3044 corresponding to the blood pressure and SpO2 of a person (Riley ¶0056); In another contemplated embodiment, the condition score comprises a modified early warning score (MEWS). According to this disclosure, the data needed to calculate the MEWS is obtained from sensors included as part of person support apparatus 3014, obtained via manual user inputs, obtained from separate monitoring equipment that communicates with controller 3074 of apparatus 3014, and/or obtained from the person's EMR. The MEWS is a known score calculated based on the following table… In the MEWS table, the various integers in the column headings are added together based on the various readings for the person of the data corresponding to the rows of the table. A score of 5 or greater indicates a likelihood of death. With regard to the systolic blood pressure, heart rate, respiratory rate, and temperature portions of the MEWS, those pieces of information are obtained using sensors 3036 of person support apparatus 3014 and/or using the other manners of obtaining a person's physiological data as discussed above (Riley ¶¶0059-0060, Table 1), wherein the Examiner notes that as indicated in Table 1 of Riley, the modified early warning score uses heart rate, respiratory rate, and temperature as inputs, and wherein continuous monitoring and diagnosis is considered to read on the claimed real-time analysis], and
a notification system providing a notification to a caregiver if the real-time early warning score exceeds a predetermined threshold [In the conditional of block 3100, if the controller 3074 determines that the condition score is greater than the threshold, then, in one illustrative embodiment, a status update including the condition score is communicated to a caregiver through the signaling and communication system 3012 and/or is displayed on the display 3040 as indicated at block 3110. That is, if the condition score exceeds the threshold, then, in some embodiments, at least one of the condition score and an alert signal are communicated to a caregiver (Riley ¶0066); It is contemplated by this disclosure that the control system 3022 is configured to predict the onset of an adverse condition and alert a caregiver. In some embodiments contemplated herein, the control system 2022 is configured to alert caregivers when a person is regaining consciousness. Alerting the caregiver when a person is regaining consciousness can be helpful in instances where the person is unconscious when admitted to a hospital and is, for example, secured to the person support apparatus, being tube fed, has broken or lost a limb, and/or lost their sight, because the person can become anxious upon regaining consciousness and can cause additional trauma to themselves before a caregiver can arrive to calm them and/or explain what is going on (Riley ¶0038)].
Regarding claim 17, Riley teaches
The early warning system of claim 11, wherein the contactless cardiopulmonary monitor is positioned on a frame member of the patient support apparatus [Riley ¶¶0039, 0041].
Regarding claim 18, Riley teaches
The early warning system of claim 17, wherein the contactless cardiopulmonary monitor is positioned beneath a mattress supporting a patient on the patient support apparatus [In some embodiments, the sensors 3036 are physiological sensors 3048 integrated into the person support surface 3026 and configured to measure various physiological parameters of a person supported on the person support surface 3026 as suggested in FIG. 7. Optionally, the physiological sensors 3048 can be coupled to the upper frame 3018, the supports 3020, and/or the lower frame 3016 in lieu of being coupled to the mattress 3046… For example, one or more of the physiological sensors 3048 are used to sense the heart rate and/or respiration rate of a person supported on the person support surface 3026 in some embodiments (Riley ¶0072)].
Regarding claim 19, Riley teaches
The early warning system of claim 11, wherein the contactless cardiopulmonary monitor is positioned beneath a mattress supporting a patient on the patient support apparatus [Riley ¶0072].
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.
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.
Claim(s) 1, 3, 5-8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riley (US-20110068935-A1) in view of Satoi (US-10602971-B2).
Regarding claim 1, Riley teaches
A patient support apparatus comprising
a diagnostic system including
a cardiopulmonary monitor detecting a patient's heart rate and respiratory rate without contacting the patient [the contact-less sensors 3046 include one or more of the following:… heart rate sensors 3064 configured to sense the rate at which the person's heart contracts; respiration rate sensors 3066 configured to sense the person's breathing rate (Riley ¶0043, Fig. 5)],
a temperature monitor [the contact-less sensors 3046 include one or more of the following:… temperature sensors 3062 configured to sense the person's body temperature (Riley ¶0043, Fig. 5)], and
utilizing data from the cardiopulmonary monitor and the patient's body temperature to establish an early warning score for the patient, the diagnostic system comparing the early warning score for the patient to a threshold early warning score indicative of an imminent adverse event [In the operation of block 3088, the controller 3074 executes the algorithm to generate a condition score corresponding to the condition of the person and/or to generate a graphic representative of the condition of the person. In one embodiment, the algorithm receives inputs from the contact-less sensors 3046 corresponding to the heart rate, respiration rate, and temperature of a person, and inputs from the contact sensors 3044 corresponding to the blood pressure and SpO2 of a person (Riley ¶0056); In another contemplated embodiment, the condition score comprises a modified early warning score (MEWS). According to this disclosure, the data needed to calculate the MEWS is obtained from sensors included as part of person support apparatus 3014, obtained via manual user inputs, obtained from separate monitoring equipment that communicates with controller 3074 of apparatus 3014, and/or obtained from the person's EMR. The MEWS is a known score calculated based on the following table… In the MEWS table, the various integers in the column headings are added together based on the various readings for the person of the data corresponding to the rows of the table. A score of 5 or greater indicates a likelihood of death. With regard to the systolic blood pressure, heart rate, respiratory rate, and temperature portions of the MEWS, those pieces of information are obtained using sensors 3036 of person support apparatus 3014 and/or using the other manners of obtaining a person's physiological data as discussed above (Riley ¶¶0059-0060, Table 1), wherein the Examiner notes that as indicated in Table 1 of Riley, the modified early warning score uses heart rate, respiratory rate, and temperature as inputs], and, if the early warning score exceeds the threshold, providing an output to initiate a therapeutic intervention to address the patient's condition [In the conditional of block 3100, if the controller 3074 determines that the condition score is greater than the threshold, then, in one illustrative embodiment, a status update including the condition score is communicated to a caregiver through the signaling and communication system 3012 and/or is displayed on the display 3040 as indicated at block 3110. That is, if the condition score exceeds the threshold, then, in some embodiments, at least one of the condition score and an alert signal are communicated to a caregiver (Riley ¶0066); It is contemplated by this disclosure that the control system 3022 is configured to predict the onset of an adverse condition and alert a caregiver. In some embodiments contemplated herein, the control system 2022 is configured to alert caregivers when a person is regaining consciousness. Alerting the caregiver when a person is regaining consciousness can be helpful in instances where the person is unconscious when admitted to a hospital and is, for example, secured to the person support apparatus, being tube fed, has broken or lost a limb, and/or lost their sight, because the person can become anxious upon regaining consciousness and can cause additional trauma to themselves before a caregiver can arrive to calm them and/or explain what is going on (Riley ¶0038)].
However, while Riley does disclose a controller for processing data from the temperature monitor [In the illustrative example, the sensors 3036 are operatively connected to the control modules 3038 and include sensors that contact the person (contact sensors 3044) and/or sensors that do not contact the person (contact-less sensors 3046) as shown in FIG. 5 (Riley ¶0041, Fig. 5); The control modules 3038 can each be configured to perform different operations, if desired. According to this disclosure, a single control module 3038 can be configured to perform the multiple different operations if desired. Optionally, a single control module 3038 can be configured to perform operations independently or in conjunction with at least one other control module 3038… Optionally, a third control module 3038, such as a physiological parameter monitor (not shown), is configured to detect a person's physiological information (Riley ¶0046); In contemplated embodiments, the control module 3038 is implemented using hardware. The control module 3038 includes a controller 3074 or processor 3074 and memory 3076 as shown in FIG. 5 (Riley ¶0048)], Riley fails to explicitly disclose the temperature monitor comprising a targeting sensor and an infrared sensor, and a controller processing data from the targeting sensor to determine a location of a feature of a patient supported on the patient support apparatus, processing data from the infrared sensor in the location of the feature of the patient to determine the patient's body temperature.
Satoi discloses systems for monitoring biological information of a subject, wherein Satoi discloses a temperature monitor comprising a targeting sensor and infrared sensor [The light detector 140 may have a configuration that allows measurement of the distance to the subject O. The distance to the subject O can be measured using a time-of-flight (TOF) technique, for instance. In the TOF technique, a time taken for irradiation light (for instance, pulsed light) to reach the light detector 140 after reflected by the subject O, in short, a time of flight is measured (Satoi Col 12:46-52); a method of obtaining biological information on a deeper portion in a noninvasive manner, near infrared spectroscopy (hereinafter, referred to as NIRS) is known. This measurement method uses electromagnetic waves (hereinafter referred to as “light”) of near-infrared wavelength range (mainly 700 nm to 1000 nm). The light in the above-mentioned wavelength range has a relatively high transmittance through a body tissue such as muscle, fat and bones, and thus called “biological window” (Satoi Col 1:49-57); The environmental control device 700 irradiates the forehead of the subject O with infrared light, and estimates a mental state, specifically, the feeling or temperature sensation of the subject O using the NIRS (Satoi Col 33:27-30)], and a controller processing data from the targeting sensor to determine a location of a feature of a subject [Information on the distribution of the distance between the subject O and the biological information detection device 100 may be generated by the calculation circuit 200 based on the output of the light detector 140 or generated by the light detector 140 and transmitted to the calculation circuit 200 (Satoi Col 12:65-13:3); The calculation circuit 200 detects the position of the test portion (forehead) of the subject O, and the distance between the light detector 140 and the forehead based on the image signal outputted from the light detector 140… The calculation circuit 200 detects the presence of the forehead and identifies the position of the forehead based on the positions of the feature points (such as the eyes, nose and mouth) in the face. In this process, the position of the forehead may be identified by pattern matching using templates associated with the human forehead. The templates are pre-stored in a ROM 152, for instance. For the image recognition, a variety of heretofore known techniques may be used without being limited to a specific technique (Satoi Col 17:9-12, 16-25, Figs. 4A-D)], processing data from the infrared sensor in the location of the feature of the subject to determine the subject’s body temperature [The calculation circuit 200 generates biological information on a target area corresponding to the test portion of the subject O in the image based on the image signal outputted from the light detector 140 (Satoi Col 17:35-38); The environmental control device 700 irradiates the forehead of the subject O with infrared light, and estimates a mental state, specifically, the feeling or temperature sensation of the subject O using the NIRS. The calculation circuit 200 of the biological information detection device 100 monitors the movement of the subject O, and identifies the subject O first. Subsequently, the calculation circuit 200 identifies the position of a test portion (for instance, forehead) of the subject O by image recognition. Based on the thus-identified position, the light source starts to irradiate the forehead with infrared light (Satoi Col 33:27-37)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the temperature monitor of the diagnostic system of the patient support apparatus to employ a targeting sensor and an infrared sensor, and a controller processing data from the targeting sensor to determine a location of a feature of a patient supported on the patient support apparatus, processing data from the infrared sensor in the location of the feature of the patient to determine the patient's body temperature, as this modification would amount to mere simple substitution of one known element for another with similar expected results [a temperature sensor for detecting a body temperature of a patient/user] [MPEP § 2143(I)(B)].
Regarding claim 3, Riley in view of Satoi teaches
The patient support apparatus of claim 1, wherein the targeting sensor comprises a time of flight sensor [See § 103 modification of claim 1 above; Satoi Col 12:46-52].
Regarding claim 5, Riley in view of Satoi teaches
The patient support apparatus of claim 1, wherein the early warning score is displayed on a graphical user interface of the patient support apparatus [The person support apparatus may comprise a hospital bed to which the display may be mounted (Riley ¶0016); in one illustrative embodiment, a status update including the condition score is communicated to a caregiver through the signaling and communication system 3012 and/or is displayed on the display 3040 as indicated at block 3110 (Riley ¶0066)].
Regarding claim 6, Riley in view of Satoi teaches
The patient support apparatus of claim 1, wherein the early warning score is displayed on a central monitoring station that is positioned remotely from the patient's location [In some embodiments, the controller 3074 communicates the alert signal wirelessly or through the signaling and communication system 3012 to one or more of a caregiver station, a mobile paging device, a cellular phone, a pendant, or remote display (not shown) (Riley ¶0080)].
Regarding claim 7, Riley in view of Satoi teaches
The patient support apparatus of claim 1, wherein an output signaling to a caregiver to initiate a therapeutic intervention to address the patient's condition is displayed on a graphical user interface of the patient support apparatus [Riley ¶¶0016, 0066].
Regarding claim 8, Riley in view of Satoi teaches
The patient support apparatus of claim 1, wherein an output signaling to a caregiver to initiate a therapeutic intervention to address the patient's condition is transmitted to a central monitoring station [Riley ¶0080].
Regarding claim 10, Riley in view of Satoi teaches
The patient support apparatus of claim 1, wherein the diagnostic system comprises a processor, the processor operable to receive signals from the cardiopulmonary monitor indicative of the heart rate and the respiratory rate of the patient, signals from the infrared sensor indicative of the patient's temperature, and process the signals according to a predetermined relationship to determine the patient's early warning score in real time [Riley ¶¶0056, 0059-0060, 0066].
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riley in view of Satoi, as applied to claim 1 above, in further view of Terry (US-20190307405-A1).
Regarding claim 2, Riley in view of Satoi teaches
The patient support apparatus of claim 1.
However, while Riley discloses that the patient support apparatus is configured to alter a function of the patient support apparatus [In some embodiments, the person support surface 3026 delivers therapy to the person, such as, for example, through sequential inflation/deflation of the fluid bladders 3028, rapid changes in pressure of the fluid in the fluid bladders 3028, passing fluid through the person support surface 3026, and/or various other techniques. For example, in various embodiments, one or more portions of the surface 3026 provide alternating pressure therapy, continuous lateral rotation therapy, low air loss therapy, boost assistance, percussion/vibration therapy, and/or other therapies. It should also be appreciated that, in some embodiments, the person support surface 3026 includes a coverlet (not shown) that overlies another person support surface 3026 and is configured to deliver therapy to a person supported thereon (Riley ¶0035); Alternatively or additionally, a second control module 3038, such as a therapy control module (not shown), is configured to sense and/or modify the pressure within the fluid bladders 3028 (Riley ¶0046)], Riley in view of Satoi fails to explicitly disclose wherein the therapeutic intervention to address the patient's condition includes altering a function of the patient support apparatus.
Terry discloses systems for assessing medical risks of a patient in a patient support apparatus, wherein Terry discloses that upon determining a pressure injury score indicative of a pressure injury risk, implementing therapeutic intervention to address the pressure injury risk by altering a function of the patient support apparatus [As indicated by the bullet points beneath the lower right image of FIG. 2, if a patient change is detected by bed 14, such as lack of patient motion or patient motion below a threshold, for a prolonged period of time, and/or if a problematic surface change is detected, then a pressure injury algorithm executed by the analytics engine 20 determines that there is an increased risk of a pressure injury and the patient's pressure injury score is increased. Furthermore, in response to the increased pressure injury score, the analytics engine 20 initiates one or more alerts to one or more caregivers of the increased pressure injury risk and, in some embodiments, automatically activates a pressure injury prevention protocol such as reducing the rounding time automatically and/or implementing a surface therapy protocol such as sending reminder messages to a caregiver to turn the patient, to activate a turn assist function of bed 14 at regular intervals (e.g., every hour or every two hours), to activate an alternating pressure therapy of the mattress of bed 14, or to activate a CLRT therapy of the mattress of bed 14 (Terry ¶0093)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patient support apparatus of Riley in view of Satoi to employ wherein the therapeutic intervention to address the patient's condition includes altering a function of the patient support apparatus, so as to automatically address the patient’s determined condition, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [apply therapy to a patient in response to a health risk assessment] [MPEP § 2143(I)(D)].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riley in view of Satoi, as applied to claim 1 above, in further view of Patil (US-20180035082-A1).
Regarding claim 4, Riley in view of Satoi teaches
The patient support apparatus of claim 1.
However, while the modification of Riley in view of Satoi teaches wherein the feature of the patient is detected using a pattern matching algorithm and that a variety of image recognition techniques may be applied [Satoi Col 17:9-12, 16-25, Figs. 4A-D], Riley in view of Satoi fails to explicitly disclose wherein the feature of the patient is detected using a machine learning algorithm.
Patil discloses systems for using a targeting sensor and processing data from the targeting sensor to determine a location of a feature of a subject, wherein the feature of the subject is detected using a machine learning algorithm [3D camera 102 with a ToF sensor, transmits pulses of light toward FoV 105, receives light reflected from objects (such as infant 1110 and scene in FoV 105. 3D camera 102 measures the time delay between the transmitted and the received pulses received at each pixel in 3D camera 102, and generates one or more raw distance images of the object/scene in FoV 105. 3D camera 102 (or the processing units contained within) processes the raw distance image(s) using well known techniques to obtain a depth image (3D image) consisting of x, y and z coordinates of each point in the scene in field of view 105 as well as the intensity (I) of the corresponding point. A processing block converts the 3D image to skeletal information of infant 111 using well known algorithms (Patil ¶0036); details such as nose, eyes, ears etc., of infant 111 are extracted after segmenting the skeletal information and analyzing individual segments in more detail using well known algorithms, as described in sections below (Patil ¶0059); Block 661 receives the outputs of block 203 (FIG. 6A), and detects the position of the head from the skeleton using machine learning based algorithms and/or deterministic approaches. Block 662 operates to segment the head (detected by block 662) to identify eyes, nose, forehead, chin and ears through the use of machine learning based algorithms (Patil ¶0118, Figs. 6A-B)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Riley in view of Satoi to employ wherein the feature of the patient is detected using a machine learning algorithm, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [use of machine learning for feature detection from depth images] [MPEP § 2143(I)(D)].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riley in view of Satoi, as applied to claim 1 above, in further view of Comeau (US-20170112418-A1).
Regarding claim 9, Riley in view of Satoi teaches
The patient support apparatus of claim 1, wherein the temperature system is positioned on a movable portion of the patient support apparatus [See § 103 modification of claim 1 above; It should also be appreciated that, in some embodiments, the supports 3020 move the upper frame 3018 to a Trendelenburg/reverse Trendelenburg position and/or rotate the upper frame 3014 from side to side with respect to the lower frame 3012 (Riley ¶0034); The sensors 3036 and/or the control modules 3038 are coupled to the upper frame 3018 in some embodiments. It should be appreciated that the sensors 3036 and/or the control modules 3038 can be coupled to the lower frame 3016, supports 3020, and/or incorporated within or coupled to the person support surface 3020 in other embodiments, if desired (Riley ¶0039); In some embodiments, the contact-less sensors 3046 are coupled to at least one of the upper frame 3018, the supports 3020, and/or the lower frame 3016. It should be appreciated that the contact-less sensors 3046 can be coupled to the casters 3024 and/or engaged by the casters 3024, if desired (Riley ¶0041)].
However, while Riley discloses that the patient support apparatus may comprise sensors to determine the position of the movable portion of the patient support apparatus [other sensors configured to sense information corresponding to the status of the person-support apparatus 3014, such as, for example, the angle of the head deck section HD with respect to the longitudinal axis X1 as shown in FIG. 5 (Riley ¶0043), wherein based on Riley ¶¶0039, 0041, the sensors may be positioned on certain portions of the patient support apparatus], Riley in view of Satoi fails to explicitly disclose wherein the diagnostic system identifies the position of the movable portion of the patient support apparatus to determine if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient.
Comeau discloses systems for capturing infrared image data of a subject, including a location of a feature of the subject, wherein Comeau discloses confirming if the subject is correctly positioned relative to an infrared camera before attempting to determine the location of the feature of the subject [At step 102, a panel shown by way of example (FIG. 2) is provided on a screen communicating with the microprocessor for a practitioner to input their file information, the subject's information, and to position the 3D infrared camera to capture the subject's target facial points, i.e., the eyes, nose, mouth, ears, cheeks, forehead, jaw, and neck. Step 104 determines if the subject has properly positioned their target facial points in front of the 3D infrared camera. If the answer is no, then step 106 is a prompt provided by the computer-implemented method to instruct the subject to adjust their position in front of the camera. If the answer is yes, then step 108 creates an avatar with a set of defined target facial points (step 110) and provides an exemplary panel for the practitioner to fix a screenshot of the target headshot and enter the parameters and criteria for the range of motion movement that will be recorded during the subject's performance of the specified movements, which in this example, are repetitive spaced-apart biting forces applied to the bite force meter (FIG. 3) (Comeau ¶0053)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diagnostic system of the patient support apparatus of Riley in view of Satoi to employ wherein the diagnostic system identifies the position of the movable portion of the patient support apparatus to determine if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient, so as to ensure proper identification of the features of the patient.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riley, as applied to claim 11 above, in view of Satoi (US-10602971-B2).
Regarding claim 13 [written in longhand format to incorporate the subject matter of claim 12 therein], Riley teaches
The early warning system of claim 11.
However, Riley fails to explicitly disclose wherein the temperature monitor includes a targeting sensor and an infrared sensor; and wherein the targeting sensor comprises a time of flight sensor.
Satoi discloses systems for monitoring biological information of a subject, wherein Satoi discloses a temperature monitor comprising a targeting sensor and infrared sensor, wherein the targeting sensor is a time of flight sensor [Satoi Col 1:49-57, 12:46-52, 33:27-30]. Satoi further discloses using the targeting sensor and infrared sensor to determine a body temperature of the subject [Satoi Col 12:65-13:3, 17:9-12, 16-25, 35-38, 33:27-37, Figs. 4A-D].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the temperature monitor of the early warning system of Riley to employ wherein the temperature monitor includes a targeting sensor and an infrared sensor; and wherein the targeting sensor comprises a time of flight sensor, as this modification would amount to mere simple substitution of one known element for another with similar expected results [a temperature sensor for detecting a body temperature of a patient/user] [MPEP § 2143(I)(B)].
Regarding claim 14, Riley in view of Satoi teaches
The early warning system of claim 11 [considered to be dependent from claim 13 based on the corresponding § 112(b) rejection and interpretation above], wherein the targeting sensor identifies a feature of the patient and the temperature monitor identifies a temperature of the patient at the feature using the infrared sensor [See § 103 modification of claim 13 above; Satoi Col 12:65-13:3, 17:9-12, 16-25, 35-38, 33:27-37, Figs. 4A-D].
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riley in view of Satoi, as applied to claim 14 above, in further view of Comeau (US-20170112418-A1).
Regarding claim 15, Riley in view of Satoi teaches
The early warning system of claim 14, wherein the temperature system is positioned on a movable portion of the patient support apparatus [Riley ¶¶0034, 0039, 0041].
However, while Riley discloses that the patient support apparatus may comprise sensors to determine the position of the movable portion of the patient support apparatus [Riley ¶¶0039, 0041, 0043], Riley in view of Satoi fails to explicitly disclose wherein the diagnostic system identifies the position of the movable portion of the patient support apparatus to determine if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient.
Comeau discloses systems for capturing infrared image data of a subject, including a location of a feature of the subject, wherein Comeau discloses confirming if the subject is correctly positioned relative to an infrared camera before attempting to determine the location of the feature of the subject [Comeau ¶0053].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the early warning system of Riley in view of Satoi to employ wherein the diagnostic system identifies the position of the movable portion of the patient support apparatus to determine if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient, so as to ensure proper identification of the feature(s) of the patient.
Regarding claim 16, Riley in view of Satoi teaches
The early warning system of claim 14.
However, while Riley discloses that the temperature monitor is positioned on a movable portion of the patient support apparatus [Riley ¶¶0034, 0039, 0041] and that the patient support apparatus may comprise sensors to determine the position of the movable portion of the patient support apparatus [Riley ¶¶0039, 0041, 0043], Riley in view of Satoi fails to explicitly disclose wherein the diagnostic system determines if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient.
Comeau discloses systems for capturing infrared image data of a subject, including a location of a feature of the subject, wherein Comeau discloses confirming if the subject is correctly positioned relative to an infrared camera before attempting to determine the location of the feature of the subject [Comeau ¶0053].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the early warning system of Riley in view of Satoi to employ wherein the diagnostic system determines if the temperature monitor is correctly positioned before attempting to determine a location of a feature of the patient, so as to ensure proper identification of the feature(s) of the patient.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riley, as applied to claim 11 above, in view of Terry (US-20190307405-A1).
Regarding claim 20, Riley teaches
The early warning system of claim 11, wherein, if the early warning score exceeds the threshold, the notification system provides an output to initiate a therapeutic intervention to address the patient's condition [Riley ¶¶0038, 0066].
However, while Riley discloses that the patient support apparatus is configured to alter a function of the patient support apparatus [Riley ¶¶0035, 0046], Riley fails to explicitly disclose wherein the therapeutic intervention to mitigate the patient's condition includes altering a function of the patient support apparatus.
Terry discloses systems for assessing medical risks of a patient in a patient support apparatus, wherein Terry discloses that upon determining a pressure injury score indicative of a pressure injury risk, implementing therapeutic intervention to address the pressure injury risk by altering a function of the patient support apparatus [Terry ¶0093].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the early warning system of Riley to employ wherein the therapeutic intervention to mitigate the patient's condition includes altering a function of the patient support apparatus, so as to automatically address the patient’s determined condition, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [apply therapy to a patient in response to a health risk assessment] [MPEP § 2143(I)(D)].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
