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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR10-2020-0187577, filed on December 30, 2020.
Information Disclosure Statement
The information disclosure statement(s) filed June 28, 2023 and September 09, 2024 has/have been considered by the Examiner.
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.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch (US 20120222214 A1 – hereinafter Lachenbruch, Applicant cited).
Re. claim 1, Lachenbruch teaches a smart mattress (abstract – “An associated bed (20) includes a mattress (82)…”) comprising:
an elastic body which elastically supports the weight of a patient (figure 12, blanket 132);
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a driving part frame, which supports the elastic body and at least a part of which is deformed to deform the elastic body (figure 12, unlabeled mattress cover, which supports the blanket 132 shown below);
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a sensor frame disposed under the driving part frame and to support the driving part frame (figure 12, bladder layer 100);
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a plurality of actuators disposed between the sensor frame and the driving part frame and driven to cause deformation of the driving part frame (figure 12, repositioning bladders 102, 104, 106, 108);
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a plurality of pressure sensors disposed to have a predetermined pattern (figure 12, pressure sensors 134) to measure a pressure that is applied by the patient to the elastic body (paragraph 0025 - “The mattress assembly also includes a sensor array 130 comprising a blanket 132 and an array of pressure or force sensors 134 installed on the blanket”; paragraph 0026 - “The controller is capable of receiving information from the sensor array, specifically signals indicating the force or pressure applied to the sensors”, further shown in figure 12);
at least one sensor for measuring biometric information of the patient (figure 12, pressure sensors 134);
and a control part (figures 5A-5B, controller 140) which drives at least some of the plurality of actuators on the basis of pressure information measured by the plurality of pressure sensors (paragraph 0039 - “…the controller is designed or configured to use the information from the sensors to identify nothing more than the mere existence of a position discrepancy and to command a preordained, open loop sequence of bladder inflation and deflation (e.g. inflate and deflate the right outboard bladder, then the right inboard bladder, then the left outboard bladder, then the left inboard bladder)”).
Lachenbruch teaches the plurality of pressure sensors as stated above (figure 12, pressure sensors 134), the sensor frame (figure 12, bladder layer 100) and the driving part frame (figure 12, unlabeled mattress cover which supports the blanket 132) as stated above, but does not explicitly teach that the plurality of pressure sensors are disposed between the sensor frame and the driving part frame.
However, despite the recitation of the essential working elements as claimed, a difference is found with respect to the layout and arrangement of the elements within the mattress. The differences in the layout and arrangement of the essential working elements are not considered to comprise a critical advantage to the layout of elements disclosed by Lachenbruch, and thus is not considered to constitute a patentable difference. Since Lachenbruch demonstrates the capability of housing each of the working elements to fit within mattress, then the architecture in which the elements are arranged is not deemed critical.
This difference, wherein the only difference being the arrangement and location of essential working elements, specifically to the plurality of pressure sensors disposed between the sensor frame and driving part frame, has been held by the reviewing courts as being obvious to one of ordinary skill in the art since it is motivated by choice in design and routine skill (In re Japikse, 86 USPQ 70), see MPEP 2144.04. A skilled designer is considered to recognize the claimed arrangement of elements as one of many possibilities for the layout of elements within the limited space created by the mattress. The location of each element is then motivated by choice in design dictated by the limited available space.
Re. claim 4, Lachenbruch further teaches wherein the at least one sensor measuring biometric information of the patient is at least one sensor selected from a temperature sensor, a pressure sensor, a weight sensor, an electrocardiogram sensor, a heartbeat sensor, and an SpO2 sensor (figure 12, pressure sensors 134).
Claim(s) 2-3, 5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch (US 20120222214 A1 – hereinafter Lachenbruch, Applicant cited) in view of Hayes (US 20160022218 A1 – hereinafter Hayes).
Re. claim 2, Lachenbruch teaches the mattress as stated above in claim 1, but does not explicitly teach the mattress further comprising at least one of: a memory which stores data that are processed in the smart mattress; a communication part including one or more communication modules for enabling the smart mattress to communicate with an external device in a wired or wireless type; and a user interface providing one or more items of information of the state of the smart mattress and the condition of the patient.
Hayes teaches a similar patient support system with patient monitoring sensors (Hayes abstract – “A person support apparatus includes sensors for monitoring aspects of a person positioned thereon”) comprising a mattress (Hayes paragraph 0102 – “Frame 26 provides a structure for supporting patient support surface 28, headboard 30, and footboard 32. Patient support surface 28 provides a surface on which a mattress…”; figure 1) and pressure sensors (Hayes paragraph 0226 – “…vital sign sensor 134 may include one or more air pressure sensors…”).
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Hayes further teaches the patient support system 20 which comprises a measurement subsystem 54 (Hayes figure 3) further comprising:
a memory which stores data that are processed in the smart mattress (Hayes figure 3, memory 58);
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a communication part including one or more communication modules for enabling the smart mattress to communicate with an external device in a wired or wireless type (Hayes similar embodiment figure 21, transceiver 132 to the mobile device 268; paragraph 0191 – “This information is made available for caregiver viewing on display 64 and/or it is transmitted to one or more servers or applications running on the healthcare computer network via transceiver 132”);
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and a user interface providing one or more items of information of the state of the smart mattress and the condition of the patient (Hayes paragraph 0205 – “As shown more clearly in FIG. 21, controller 56 communicates with additional electronic components besides vital signs sensor 134, such as a memory 58, a wireless transceiver 132, and a user interface 60”).
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Lachenbruch and Hayes both teach within the field of patient support apparatuses, specifically with pressure sensors as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient support mattress of Lachenbruch, to incorporate the memory, communication part and user interface as taught by Hayes, since such modification would predictably result in, for example, adjusting diagnosis, and/or treatment so as to improve the quality of the care delivered to that patient (Hayes paragraph 0256).
Re. claim 3, the combined invention of Lachenbruch and Hayes (hereinafter the combined invention) further teaches wherein one or more of data about an operation pattern of the driving part, an operation time of the driving part, the operation number of times of the driving part, a sleep pattern of the patient, and information obtained from the at least one sensor are stored in the memory (Hayes paragraph 0205 – “Memory 58 stores the instructions used by controller 56 to carry out its algorithms, as well as the data gathered from vital signs sensor 134”),
the external device includes a terminal that can connect with a wearable device that the patient wears or an EMR system (Hayes paragraph 0131 – “…the weight event log entries are forwarded to one or more healthcare network applications or servers running on a healthcare network. Such applications or servers may include, among others, an electronic medical record system”, which then connects to the external mobile devices 268 shown in figure 21),
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and the user interface shows one or more of biometric information of the patient, the shape of the mattress, the posture of the patient, and notice information (Hayes paragraph 0118 – “…measurement subsystem 54 communicates with display 64 on user interface 60…”; figure 21 also shows the vital sign sensor 134 which sends signals to the controller 56, which in turn sends the signals to the user interface 60, paragraph 0205 – “…controller 56 communicates with additional electronic components besides vital signs sensor 134, such as a memory 58, a wireless transceiver 132, and a user interface 60”; see also paragraphs 0181-0182).
Re. claim 5, Lachenbruch teaches the pressure sensor as stated above in claim 4 (figure 12, pressure sensors 134).
Lachenbruch does not explicitly teach wherein the temperature sensor further senses temperature around the smart mattress; posture variation of the patient is sensed on the basis of information measured by the weight sensor and information measured by the pressure sensor; the electrocardiogram sensor senses electrocardiogram information before the patient receives treatments on the smart mattress, electrocardiogram information that is changed while the patient receives treatments and electrocardiogram information after the patient receives treatments; and the heartbeat sensor senses heartbeat information before the patient receives treatments on the smart mattress, heartbeat information that is changed while the patient receives treatments, and heartbeat information after the patient receives treatments.
Hayes teaches a similar patient support system with patient monitoring sensors (Hayes abstract – “A person support apparatus includes sensors for monitoring aspects of a person positioned thereon”) comprising a mattress (Hayes paragraph 0102 – “Frame 26 provides a structure for supporting patient support surface 28, headboard 30, and footboard 32. Patient support surface 28 provides a surface on which a mattress…”; figure 1) and pressure sensors (Hayes paragraph 0226 – “…vital sign sensor 134 may include one or more air pressure sensors…”).
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Hayes further teaches the system comprises temperature sensors (Hayes paragraph 0175 – “…measurement subsystem 54 and/or 54a can also include communication between controller 56 and one or more temperature sensors”),
Weight sensors (Hayes paragraph 0018 – “…the controller determines a baseline weight sensed by the sensors”; paragraph 0039 – “The plurality of force sensors may be adapted to measure a weight of a patient positioned on the support surface…”),
electrocardiogram sensors (Hayes paragraph 0203 – “…vital sign sensor may be modified to include the ability to sense a patient's ECG…”),
and heartbeat sensors (Hayes paragraph 0204 – “…vital sign sensor 134 communicates its detected signals indicative of heart rate and/or breathing rate to controller 56 positioned on board patient support apparatus 20c…Controller 56 receives the outputs of vital sign sensor 134 and processes them to determine the heart rate…”).
Furthermore, it is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART. Therefore, it is interpreted by the Examiner that Hayes sufficiently teaches the structural limitations and thus satisfies the intended use limitations of the claim.
Lachenbruch and Hayes both teach within the field of patient support apparatuses, specifically with pressure sensors as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient support mattress of Lachenbruch, to incorporate the temperature, weight, ECG and heart beat sensors as taught by Hayes, since such modification would predictably result in, for example, adjusting diagnosis, and/or treatment so as to improve the quality of the care delivered to that patient (Hayes paragraph 0256).
Re. claim 9, Lachenbruch teaches a medical management system comprising:
the smart mattress of claim 1 (see claim 1 rejection above).
Lachenbruch does not further teach a server transmitting and receiving information to and from the smart mattress.
Hayes teaches a similar patient support system with patient monitoring sensors (Hayes abstract – “A person support apparatus includes sensors for monitoring aspects of a person positioned thereon”) comprising a mattress (Hayes paragraph 0102 – “Frame 26 provides a structure for supporting patient support surface 28, headboard 30, and footboard 32. Patient support surface 28 provides a surface on which a mattress…”; figure 1) and pressure sensors (Hayes paragraph 0226 – “…vital sign sensor 134 may include one or more air pressure sensors…”).
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Hayes further teaches a server transmitting and receiving information to and from the smart mattress (Hayes paragraph 0191 – “The patient turn feature automatically detects which position 172, 174, or 176 the patient is in, automatically records the time at which a change in these positions occurs and the type of change…This information is made available for caregiver viewing on display 64 and/or it is transmitted to one or more servers or applications running on the healthcare computer network via transceiver 132”; figure 24, servers 266).
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Lachenbruch and Hayes both teach within the field of patient support apparatuses, specifically with pressure sensors as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient support mattress of Lachenbruch, to incorporate the server as taught by Hayes, since such modification would predictably result in, for example, adjusting diagnosis, and/or treatment so as to improve the quality of the care delivered to that patient (Hayes paragraph 0256).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch (US 20120222214 A1 – hereinafter Lachenbruch, Applicant cited) in view of Nunome (US 20020196148 A1 – hereinafter Nunome).
Re. claim 6, Lachenbruch teaches the biometric and pressure sensing as stated above in claims 1 and 4 (figure 12, pressure sensors 134).
Lachenbruch does not explicitly teach wherein the control part sets data within a predetermined range of biometric signal data measured by the at least one sensor and pressure data measured by the pressure sensor as normal range data and sets generation of data out of the normal range data as event data.
Nunome teaches a similar patient support apparatus (Nunome abstract – “An apparatus for detecting a patient, including a plurality of pressure detecting devices which are adapted to be placed on a bed such that the pressure detecting devices are arranged in a widthwise direction of the bed…”) with pressure sensors (Nunome paragraph 0026; figure 2, pressure sensors 20) and a control part (Nunome figure 1, control device 28).
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Nunome further teaches wherein the control part sets data within a predetermined range of biometric signal data measured by the at least one sensor and pressure data measured by the pressure sensor as normal range data and sets generation of data out of the normal range data as event data (Nunome teaches setting a signal data range with a pressure threshold TH to reach in order to determine if a patient is present in the bed based on pressure sensors, paragraph 0028 – “…if at least one of the respective air pressures of the bags 16 is higher than a prescribed threshold value TH that is higher than the initial pressure, that the patient is present on the bed 12. On the other hand, if all the respective air pressures of the bags 16 are not higher than the prescribed threshold value TH, the patient detecting means 52 judges that the patient is not present on the bed 12”, also elaborated in paragraph 0029).
Lachenbruch and Nunome both teach within the field of patient support apparatuses, specifically with pressure sensors as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient support mattress of Lachenbruch, specifically the control part, to incorporate the prescribed pressure signal data thresholds as taught by Nunome as stated above, since such modification would predictably result in allowing for determining if a patient is present on a bed (Nunome paragraph 0002).
Re. claim 7, the combined invention of Lachenbruch and Nunome further teaches wherein the control part sets the event data as falling event sign data, and provides an alarm signal when one or more of the biometric signal data measured by the at least one sensor and the pressure data measured by the pressure sensor correspond to the falling event sign data (Nunome paragraph 0028 – “…if all the respective air pressures of the bags 16 are not higher than the prescribed threshold value TH, the patient detecting means 52 judges that the patient is not present on the bed 12. In the latter case, the patient detecting means 52 operates the signal transmitter 36 to transmit a signal representing an alarm that the patient is not present on the bed 12”).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lachenbruch (US 20120222214 A1 – hereinafter Lachenbruch, Applicant cited) in view of Hwang (US 4956884 A – hereinafter Hwang).
Re. claim 8, Lachenbruch teaches the obvious invention of the smart mattress module comprising an elastic body which elastically supports the weight of a patient; a driving part frame, which supports the elastic body and at least a part of which is deformed to deform the elastic body; a sensor frame disposed under the driving part frame to support the driving part frame; a plurality of actuators disposed between the sensor frame and the driving part frame and driven to cause deformation of the driving part frame; and a plurality of pressure sensors disposed to have a predetermined pattern between the sensor frame and the driving part frame to measure a pressure that is applied by the patient to the elastic body (see claim 1 rejection above).
Lachenbruch not explicitly teach wherein one mattress is formed by coupling a plurality of smart mattress modules that are unit bodies including at least a portion of the configuration of the smart mattress.
Hwang teaches a similar mattress (Hwang abstract – “A modular box spring mattress includes two flexible plate units each of which consists of a plurality of plate subunits”; figure 1).
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Hwang further teaches the known elements of a mattress coupling a plurality of mattress that are unit bodies including at least a portion of the configuration of the mattress (Hwang figure 1, mattress includes plate units 1 further comprising a plurality of plate subunits 10; column 2, lines 6-11: “Referring to FIG. 1, a modular box spring mattress of this invention includes upper and lower generally rectangular plate units 1 and a plurality of coiled compression springs 2 interposed between the plate units 1. Either of the plate units 1 consists of a plurality of generally rectangular plate subunits 10”).
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Both Lachenbruch and Hwang teach within the field of mattresses; Lachenbruch teaches the smart mattress as a single unit, while Hwang teaches the mattress with the known elements of a plurality of subunits as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the smart mattress unit comprising the elastic body, driving part frame, sensor frame, plurality of actuators and plurality of pressure sensors of Lachenbruch as stated above, to incorporate the known technique of using plurality of mattress subunits as taught by Hwang, since such modification would predictably result in greater efficacy in sensing biometric and/or pressure signal data in sections of the mattress.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796