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). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The certified copy was received on April 8, 2025.
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.
Claims 3, 4, and 9 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.
As for Claim 3
Claim 3 uses the phrase “and/or” which renders the claim indefinite.
The method of claim 2, wherein the detected deformation comprises a detected degree of deformation, and the control signal is generated in dependence on the detected degree of deformation; and/orwherein the detected deformation comprises a detected deformation direction, and the control signal is generated in dependence on the detected deformation direction; and/orwherein the sensor comprises a strain gauge, which is mechanically coupled with at least a portion of the actuating element, and the sensor signal indicates as the detected deformation an electric voltage present at terminals of the strain gauge and/or an electric current flowing between terminals of the strain gauge.
The repeated use of “and/or” creates multiple alternative combinations of limitations, which may make the scope of the dependent claim unclear under MPEP § 2173.
Rewriting the claim using separate dependent claims or recite “at least one of” followed by a clearly enumerated list of alternatives should help clarify the issue.
As for Claim 4
Claim 4 uses the phrase “the voltage and/or of the current” which renders the claim indefinite.
The method of claim 3, wherein a deviation of an amplitude of the voltage and/or of the current from a threshold value is determined, and the control signal is generated in dependence on the deviation.
The phrase “the voltage and/or of the current” may lack clear antecedent basis because claim 3 only optionally recites the strain-gauge voltage/current limitation through “and/or” language.
By making the claim 4 depend from a claim that expressly requires the strain gauge voltage/current limitation, or incorporate the strain gauge voltage/current language directly into claim 4 should remedy the issue.
As for Claim 9
Claim 9 uses the phrase “defined bending force” which renders the claim indefinite.
The operating device of claim 8, wherein the actuating element is plate-like and/or formed of metal; and/or wherein the actuating element is rigidly connectable at its first end to a fastening portion of the medical device and is actuatable by application of a defined bending force to its second, free end.
The term “defined bending force” may be indefinite because the claim and specification do not appear to provide an objective value, range, standard, or test for what force is “defined.”
Clarifying whether the “defined bending force” means a predetermined force, a force sufficient to elastically deform the actuating element, or a specified force/range should clear he problem. However, the specification repeats similar language at ¶ [0043], but does not appear to define the force magnitude or objective boundary.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kappeler (US20080086815) in view of Shelton (US20190200977), further in view of Monson (US20230277397), Chassoulier (US20170130810), and/or Boone (US20040236174).
Where appropriate, official notice is invoked for routine features (e.g., PCBs, spacers, sealing).
Obviousness Rationale for Combining References
Motivation: All references seek to provide user-friendly, ergonomic, and reliable control of medical device actuators. Combining user-actuated strain gage input (Kappeler, Shelton) with feedback devices (Monson) and known actuator control techniques (Chassoulier) and an incubator based on a platform that is movable (Boone) and it would have been obvious to one of ordinary skill to improve usability, safety, and reliability and ease of use.
Official Notice: Routine features such as mounting PCBs, using spacers, and sealing for protection are so well known that Official Notice is appropriate.
Claims 1–18 are rejected under 35 U.S.C. § 103 as being unpatentable over Kappeler in view of Shelton, further in view of Chassoulier, Monson, and Boone, as set forth below.
Claim 1
Regarding claim 1, Kappeler discloses a method for controlling an actuator system of a medical device, wherein the medical device is a patient support apparatus such as a hospital bed or stretcher having a powered transport device including a motor-driven wheel and a controller for controlling the motor to propel the patient support apparatus along a floor. See Kappeler ¶¶ [0045]–[0048]. Kappeler further discloses that the patient support apparatus includes an operating device for operating the powered transport device, including push handles coupled to the frame and grippable by a user to maneuver the patient support apparatus. See Kappeler ¶¶ [0083]–[0086].
Kappeler discloses that the push handle assembly includes a strain gage assembly/load cell having multiple strain gauges arranged on the mounting tube, wherein pushing or pulling the push handle causes bending or deformation of the mounting tube and results in a corresponding signal being sent to the controller. See Kappeler ¶¶ [0084]–[0087]. Kappeler further teaches that when the push handle is pushed forwardly, certain strain gauges are compressed and others are stretched to send a first input signal to the controller, and when the push handle is pulled rearwardly, the strain gauges produce a second input signal to the controller. See Kappeler ¶ [0086]. Thus, Kappeler teaches receiving a sensor signal indicating deformation of a hand-actuated actuating element and generating a control signal for controlling an actuator system using that signal.
To the extent Kappeler does not expressly use the same terminology as Applicant, Shelton teaches a surgical instrument having a strain gage circuit in communication with a motor control circuit, wherein strain within the surgical instrument is sensed and the motor speed is changed based on input from the strain gage circuit. See Shelton claims 1, 14, and 18; see also Shelton ¶¶ [0724]-[0726], [2352]–[2364] and ¶¶ [2385]–[2394].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the strain-gage-based user input and motor control teachings of Shelton with the patient support apparatus control system of Kappeler because both references address user or instrument input sensing for controlling powered medical-device actuators, and the combination would have predictably improved ergonomic and reliable actuator control. Therefore, claim 1 is obvious over Kappeler in view of Shelton.
Claim 2
Regarding claim 2, Kappeler discloses feedback devices for the user of the patient support apparatus, including speed indicator LEDs, battery power indicator LEDs, direction indicator LEDs, and service-required LEDs associated with the user interface. See Kappeler ¶¶ [0055]–[0061], [0091]–[0093], and [0096]. Kappeler further discloses that the controller operates these indicators in connection with the propulsion control state and user input. See Kappeler ¶¶ [0059]–[0061] and [0101]–[0103].
Monson likewise teaches user feedback in a patient support apparatus having powered propulsion and control circuitry, including user interface indicators and control feedback associated with operation of a powered patient support apparatus. See Monson, e.g., ¶¶ [0171], [0210], [0212], [0244]–[0256], and [0328]–[0336].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide acoustic, visual, and/or haptic feedback in the Kappeler/Shelton system because feedback to confirm activation or operating state of a medical device is a predictable and conventional safety and usability enhancement. Thus, it would have been obvious to generate an additional control signal for a feedback device using the same sensor signal or actuator control signal already used to control the actuator system.
Claim 3
Regarding claim 3, Kappeler teaches that the strain gage/load cell output changes depending on how the handle is pushed or pulled, and that the signal is used to control movement of the patient support apparatus. See Kappeler ¶¶ [0084]–[0087]. Kappeler further teaches that in some embodiments the speed of the drive wheel motor is proportional to the force with which one or both push handles are pushed forwardly or pulled rearwardly. See Kappeler ¶ [0095]. Thus, Kappeler teaches generating the control signal in dependence on the detected degree of deformation.
Kappeler also teaches that pushing the handle forwardly produces a first input signal and pulling the handle rearwardly produces a second input signal, thereby teaching control based on deformation direction. See Kappeler ¶¶ [0086]–[0087]. Shelton further teaches the use of strain gage signals, including electrical signals, to alter operation of a powered surgical instrument. See Shelton claims 1, 14, and 18 ¶¶ [0724]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, the combined teachings render obvious detecting degree and direction of deformation and generating actuator control based thereon.
Claim 4
Regarding claim 4, Kappeler teaches that sufficient pushing or pulling force applied to the handle produces signals that cause the controller to operate the transport device. See Kappeler ¶¶ [0053]–[0054], [0086]–[0087]. To the extent Kappeler does not expressly disclose comparing the amplitude of a voltage or current from the strain gage against a threshold value, Chassoulier expressly teaches a control module connected to a group of strain gauges and configured to compare the amplitude of the strain gauge signal against at least one predetermined value. See Chassoulier ¶¶ [0005], [0017]–[0018], [0042]–[0048], and claim 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the threshold comparison technique of Chassoulier into the Kappeler/Shelton user input system because comparing a sensor signal to a threshold is a known and predictable way to avoid inadvertent actuation and to ensure that actuator control occurs only when a sufficient user input has been detected. Therefore, claim 4 is obvious.
Claim 5
Regarding claim 5, Kappeler discloses a load cell including four strain gauges or resistors electrically connected to form a Wheatstone bridge, with two resistors located on an inner sidewall of the mounting tube and two resistors located on an outer sidewall of the mounting tube. See Kappeler ¶ [0084]. Kappeler further teaches that pushing and pulling the handle causes different strain conditions in these different portions of the handle assembly, which are used to provide signals to the controller. See Kappeler ¶¶ [0084]–[0087].
To the extent claim 5 requires separately receiving first and second sensor signals from different sensor elements, Chassoulier teaches use of multiple strain gauges, including groups of strain gauges connected as Wheatstone bridges and multiple gauge groups for redundancy. See Chassoulier ¶¶ [0007], [0041], and Fig. 2b.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use multiple strain gauge elements or multiple strain gauge signals in Kappeler’s handle assembly to improve sensitivity, accuracy, and redundancy of deformation detection. Therefore, claim 5 is obvious.
Claim 6
Regarding claim 6, Kappeler discloses multiple push handle assemblies on the patient support apparatus, and teaches that both push handle assemblies may include the push handle enable switch and the strain gage assembly. See Kappeler ¶¶ [0083]–[0087] and [0095]. Each push handle is an actuating element actuatable by hand, and each strain gage assembly detects deformation of the corresponding handle structure. Thus, Kappeler teaches or at least suggests a further actuating element and a further sensor.
Further Monson discloses multiple user input devices/interfaces for actuator control ([0210], [0212]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide multiple strain-gage-based user input handles on a patient support apparatus so that a caregiver may control the powered transport system from more than one location, thereby improving usability and maneuverability of the patient support apparatus. Accordingly, claim 6 is obvious.
Claim 7
Regarding claim 7, Kappeler discloses a controller for receiving signals from the user interface, strain gage/load cell, caster brake position sensor, and other components, and for controlling operation of the drive motor and associated powered transport device. See Kappeler ¶¶ [0047]–[0049], [0084]–[0087]. Shelton similarly discloses a motor control circuit or motor control system that receives data from a strain gage circuit and changes operation of the motor based thereon. See Shelton claims 1, 13, 14, 18, and 19.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to the teachings of Kappeler in view of Shelton, a signal processing device comprising elements configured to carry out the method of claim 1.
Claim 8
Regarding claim 8, Kappeler discloses an operating device for operating a medical device, namely a push handle assembly for a powered patient support apparatus. See Kappeler ¶¶ [0083]–[0087]. The push handle is actuatable by hand, the load cell/strain gage assembly detects deformation of the handle assembly on actuation, and the controller processes the resulting signal to operate the powered transport device. See Kappeler ¶¶ [0084]–[0087]. Shelton further confirms that strain gage sensor signals may be used by a motor control circuit to control a powered medical/surgical instrument. See Shelton claims 1, 14, and 18 and ¶¶ [0212], [0724]. Accordingly, the operating device of claim 8 is rendered obvious.
Claim 9
Regarding claim 9, Kappeler discloses a push handle assembly including a bent tube and a mounting tube. See Kappeler ¶¶ [0083]–[0087] and Figs. 13–15. Kappeler further discloses that the mounting tube is made of alloy steel seamless tubing. See Kappeler ¶ [0087]. The push handle assembly is rigidly connected to the upper frame or mounting bracket and is actuatable by applying pushing or pulling force, which bends or deforms the mounting tube and produces the strain gage signal. See Kappeler ¶¶ [0084]–[0087]. Therefore, Kappeler teaches an actuating element formed of metal and rigidly connected at a first end to a fastening portion of the medical device, and actuatable by bending force.
Claim 10
Regarding claim 10, Kappeler discloses that electrical wires from the load cell extend to a circuit board situated within the interior region of the mounting tube. See Kappeler ¶ [0085]. Thus, Kappeler teaches that at least one component of the operating device is arranged on a circuit board associated with the actuating handle assembly.
To the extent Kappeler does not expressly state that the printed circuit board is fastened to the actuating element, it would have been obvious to fasten the circuit board to the handle or mounting tube structure to mechanically support the electronics and maintain electrical connections to the strain gage assembly. Official notice is taken that mounting electronic components on printed circuit boards and fastening such boards to supporting structure is notoriously old and well known in the electronic device arts. See MPEP § 2144.03. Official Notice is hereby taken, that electronic components such as sensors, signal processing devices, and feedback circuits are routinely mounted on printed circuit boards (PCBs), which are commonly fastened to structural elements of devices using spacers to provide separation, and that such assemblies may be sealed to protect against environmental contaminants. These features are conventional and do not, in themselves, confer patentable weight. Therefore, claim 10 is obvious.
Claim 11
Regarding claim 11, Kappeler discloses a handle assembly including a mounting tube, circuit board, strain gage assembly shield, bellows, and associated mechanical support structure. See Kappeler ¶¶ [0085]–[0089]. These structures provide physical spacing and protection for electronics in the handle assembly.
To the extent Kappeler does not expressly disclose a printed circuit board fastened by a spacer to define a gap, official notice is taken that fastening a PCB to a support structure using spacers to separate the PCB from adjacent structures is a routine and conventional technique used to prevent electrical shorts, provide clearance for components, improve mechanical support, and protect electronics. See MPEP § 2144.03. It would have been obvious to use such spacers in Kappeler’s handle assembly for these predictable benefits. Therefore, claim 11 is obvious.
Claim 12
Regarding claim 12, Kappeler discloses protective features for the handle assembly including flexible bellows, compression gasket, and a strain gage assembly shield. See Kappeler ¶¶ [0085]–[0089]. Kappeler teaches that the bellows cover portions of the push handle assembly without interfering with movement, and the shield protects the strain gage assembly. See Kappeler ¶¶ [0087]–[0089]. These features teach protecting internal electronic and sensor components from environmental influences.
To the extent a specifically sealed gap is not expressly recited in Kappeler, official notice is taken that sealing gaps around electronics to protect against moisture, dirt, fluids, and other environmental contaminants is a routine and conventional design practice in medical and industrial electronic devices. See MPEP § 2144.03. Therefore, claim 12 is obvious.
Claim 13
Regarding claim 13, Kappeler discloses visual feedback devices on the user interface, including speed indicator LEDs, battery indicator LEDs, service required LEDs, and direction LEDs. See Kappeler ¶¶ [0055]–[0061], [0091]–[0096], and [0101]–[0103]. Monson likewise discloses user feedback associated with a powered patient support apparatus, including visual and other feedback for operation of the apparatus. See Monson ¶¶ [0171], [0244]–[0256], and [0328]–[0336]. Boone further discloses alarms for patient monitoring in an infant care apparatus. See Boone ¶¶ [0030]–[0035].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include at least one component of the feedback device on the printed circuit board because LEDs, displays, speakers, and vibration control circuits are conventionally mounted on PCBs in user interface assemblies. The combination merely applies known feedback electronics to Kappeler’s strain-gage-based medical-device operating device with predictable results. Therefore, claim 13 is obvious.
Claim 14
Regarding claim 14, Kappeler discloses a patient support apparatus having a powered transport actuator system and a user operating device including push handles and user interface controls. See Kappeler ¶¶ [0045]–[0049], [0083]–[0087]. The operating device includes the strain-gage-based deformation sensing structure discussed above with respect to claims 1 and 8. Monson likewise teaches a patient support apparatus with powered casters, power drive circuitry, and user input for controlling propulsion. See Monson ¶¶ [0171]–[0186], [0244]–[0256]. Therefore, claim 14 is obvious.
Claim 15
Regarding claim 15, Boone discloses an infant care apparatus including an incubator or patient support module for caring for infants in a controlled environment. See Boone ¶¶ [0001]–[0003] and [0025]–[0027]. Boone further discloses infant care systems including a radiant heater and convective heater system. See Boone ¶ [0027]. Thus, Boone teaches a heat therapy device within the meaning of Applicant’s claim.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the user-actuated strain-gage-based control arrangement of Kappeler/Shelton to a heat therapy device such as Boone’s incubator because both are medical devices having controllable functions, and using a deformation-based user input would predictably provide robust, ergonomic, and low-wear operation. Therefore, claim 15 is obvious.
Claim 16
Regarding claim 16, Kappeler discloses a patient support apparatus including a patient support deck and elevation adjustment mechanisms that raise, lower, and tilt the upper frame relative to the base frame. See Kappeler ¶ [0045]. Kappeler further discloses actuators associated with powered movement of the patient support apparatus. See Kappeler ¶¶ [0047]–[0049]. Monson also discloses a patient support apparatus having a frame and actuator systems for movement of patient support structures and powered caster systems. See Monson ¶¶ [0171]–[0186], [0210], [0244]–[0256].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the deformation-based user input of Kappeler/Shelton to control a lying surface adjustment actuator because powered patient support adjustment and user-operated actuator controls are known features of patient support apparatuses and the combination would provide predictable ergonomic control. Therefore, claim 16 is obvious.
Claim 17
Regarding claim 17, Boone discloses an infant incubator or patient care apparatus having an incubator chamber for accommodating an infant, including a platform and canopy that cooperate to enclose the infant in an isolation chamber. See Boone ¶¶ [0025]–[0028], [0033]–[0040]. Boone further discloses a canopy mounted on a lift arm for vertical movement between opened and closed positions. See Boone ¶ [0026]. Thus, Boone teaches an incubator chamber and a movable hood/canopy structure [0002], [0067], [0069] and [0071].
Kappeler and Monson teach actuator systems and controllers for moving components of medical patient support apparatuses. See Kappeler ¶¶ [0047]–[0049] and Monson ¶¶ [0171]–[0186]. It would have been obvious to motorize or otherwise actuator-control Boone’s movable canopy/lift structure using the actuator control teachings of Kappeler/Monson, and to employ the deformation-based operating device of Kappeler/Shelton, because motorized adjustment of medical device structures reduces caregiver effort, improves ergonomics, and provides predictable automated control of movable patient care components. Therefore, claim 17 is obvious.
Claim 18
Regarding claim 18, Kappeler discloses a patient support apparatus having a mobile frame with a plurality of casters and a powered transport device including a drive motor and controller. See Kappeler ¶¶ [0045]–[0049]. Kappeler further teaches caster braking mechanisms and powered transport control. See Kappeler ¶¶ [0045]–[0049] and [0113]–[0117]. Monson discloses a patient support apparatus having a mobile frame, castors, powered dual-wheel motorized casters, power drive circuitry, drive devices, braking devices, steering devices, and collision avoidance or control features. See Monson ¶¶ [0171]–[0186], [0244]–[0264], and [0328]–[0336].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Kappeler’s deformation-based user input/control handle with Monson’s powered mobile patient support apparatus because both references are directed to powered movement of patient support apparatuses and the combination would predictably provide ergonomic, robust, and user-friendly control of drive, braking, and/or steering functions. Therefore, claim 18 is obvious.
Conclusion
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/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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