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 .
DETAILED ACTION
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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).
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Claim 6-14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6-14 of U.S. Patent No. 11,768,929 B2. Although the claims are not identical, they are not patentably distinct from each other.
Claim 6 of U.S. Patent No. 11,768,929 B2 recites a method of restricting access to a control panel of a metering pump comprising “receiving a user input signal from a user interface,” “determining the user input signal is a lockout access code,” and “switching the metering pump between a locked configuration and an unlocked configuration based on a receipt of the lockout access code.” Claim 6 of the ’929 patent further recites that, in the locked configuration, “an operational parameter of the metering pump is maintained in response to the user input signal,” and, in the unlocked configuration, “the operational parameter is adjusted in response to the user input signal,” and further recites “performing a prime function when in the locked or unlocked configuration.”
The presently claimed invention merely narrows and recasts the patented method by specifying that, in the locked configuration, the control unit selectively permits the pump to provide a prime function while keeping an operational parameter maintained. This limitation is not patentably distinct from patented claim 6, which already recites maintaining the operational parameter in the locked configuration and performing a prime function when in the locked or unlocked configuration. Thus, the presently claimed method is an obvious variant of the method already claimed in U.S. Patent No. 11,768,929 B2.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Valego et al. (US 2007/0088269 A1) in view of Mann et al. (US 2003/0181851 A1).
Regarding claim 6, Valego teaches a method of restricting access to a control panel of a metering pump. Valego teaches a pumping apparatus including “a pump for controlling the flow of fluid to the patient,” “a controller for controlling the operation of the pump,” and “a user interface operatively connected to the controller comprising a plurality of push buttons” (claim 1). Valego further teaches that the pump includes a “lockout system 110” that places the pump in a locked state in which push buttons on the user interface are deactivated to prevent the operation of the pump from being accidentally or inadvertently changed (para. 0019).
Valego teaches receiving a user input signal from a user interface and determining the user input signal is a lockout access code. In particular, Valego teaches that the instructions determine whether “the lockout button 21a is depressed and held for four seconds” and that, when the push button is depressed for the predetermined time, the instructions display the locked icon and deactivate the push buttons on the user interface except the lockout button (para. 0020). Valego also teaches that the lockout button is depressed and held for four seconds in the locked state to activate all push buttons and return the pump to the unlocked state (para. 0021).
Valego teaches switching the metering pump between a locked configuration and an unlocked configuration based on a receipt of the lockout access code. Valego teaches that the lockout push button is used to transfer the pump “from the unlocked state to the locked state,” and that pressing and holding the lockout push button in the locked state changes the status of the pump to the unlocked state (paras. 0020-0023).
Valego teaches wherein in the locked configuration, the control unit selectively permits the pump to provide a prime function while keeping an operational parameter of the metering pump maintained in response to the user input signal. Valego teaches that the lockout push button is a multifunctional button “used to select the ‘PRIMING’ mode of the pump” and also “used to initiate the lockout system 110” (para. 0020). Valego further teaches that, in the locked state, “the microprocessor 65 continues to run the pump in the normal mode with the previously established settings” (para. 0020). Valego also teaches that the lockout push button is used to select the “PRIMING” function of the pump so that the pump is primed when the lockout push button is depressed and released (para. 0025). However, Valego does not expressly teach that the prime function is selectively permitted while the pump is in the locked configuration.
Mann teaches an external infusion device with a lockout function having multiple lockout levels. Mann teaches that, in a “Setup” lockout level, the user is locked out of changing setup parameters, but “will only have access to activated features of the external infusion device 10” and “cannot change the pre-set parameters” (para. 0148). Mann further teaches that a “Special key sequence (or code)” is required to change the lockout level (para. 0150), and that the physician or sophisticated user can select only the external infusion device capabilities required for an individual user, while a lockout capability enables exclusion of certain options from the user (para. 0151). Mann also teaches a prime function as one of the pump menu options, including setting a prime amount and operating the pump to prime the infusion device (Fig. 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Valego’s pump lockout method to permit selected activated pump features, including the known prime function of Valego, to remain accessible in the locked configuration while preventing changes to pre-set operating parameters, as taught by Mann. The motivation would have been to allow a caregiver or authorized user to preserve safety-critical operating parameters and prevent unauthorized adjustment while still allowing selected pump functions needed for normal pump use, maintenance, or setup, such as priming, to be performed without fully disabling the pump interface.
Valego teaches wherein in the unlocked configuration, the operational parameter is adjusted in response to the user input signal. Valego teaches that the push buttons provide inputs to the controller when depressed in the unlock state, and at least some inputs are capable of causing the controller to change operation of the pump (claim 1). Valego also teaches that, when the unlock state is re-initiated, the push buttons are enabled and an authorized user or caregiver may control the operation of the pump by using the push buttons to change the operating mode or operating parameters of the pump (para. 0026).
Claims 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Valego et al. (US 2007/0088269 A1) in view of Mann et al. (US 2003/0181851 A1), and further in view of Wang et al. (US 2009/0277535 A1).
Regarding claim 7, Valego in view of Mann teaches the method of claim 6 as set forth above.
Valego teaches displaying lockout status information on the pump display. In particular, Valego teaches that the display screen displays a locked padlock symbol when the pump is in the locked state and an unlocked padlock symbol when the pump is in the unlocked state (para. 0019). Valego further teaches that the lockout button is depressed and held for four seconds to place the pump in the locked state and is depressed and held for four seconds in the locked state to return the pump to the unlocked state (paras. 0020-0021). However, Valego does not expressly teach displaying a passkey notice that provides an instruction on how to generate the lockout access code with the user interface.
Wang teaches a liquid dispensing apparatus having locked and unlocked dispensing modes and a visual display. Wang teaches that, in a locked mode, “if the user depresses unlock/exit button 407 for three seconds,” the user can unlock dispensing and dispense water (para. 0095). Wang further teaches that the LCD display may display an error message stating “PRESS AND HOLD UNLOCK FOR 3 SEC,” which means the child safety button is locked (para. 0098).
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 pump lockout method of Valego, as modified by Mann, to display a passkey notice that provides an instruction on how to generate the lockout access code with the user interface, as taught by Wang. The motivation would have been to improve user guidance and usability of the lockout system by informing an authorized user of the specific user-interface action required to unlock the device, while still preventing unintended or unauthorized adjustment of operating parameters.
Regarding claim 8, Valego teaches wherein displaying comprises displaying the passkey notice on the metering pump. Valego teaches that the pump includes a display screen and that the display screen displays lockout status information, including a locked padlock symbol when the pump is in the locked state and an unlocked padlock symbol when the pump is in the unlocked state (paras. 0019-0020). Valego also teaches that the display screen is part of the pump user interface.
Wang further teaches displaying a lockout/passkey instruction on the device display. Wang teaches that error messages may appear in LCD display 307, including “PRESS AND HOLD UNLOCK FOR 3 SEC,” which means the child safety button is locked (para. 0098).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to display the passkey notice on the pump display of Valego, as modified by Mann and Wang, because Valego already provides a display screen on the pump for lockout status information, and Wang teaches displaying the unlock instruction on the device display to inform the user how to unlock the device. The motivation would have been to improve usability by providing the lockout instruction directly at the user interface where the user interacts with the locked control panel.
Regarding claim 9, Valego discloses wherein displaying comprises displaying the passkey notice within or on a packaging of the metering pump (display 115/119 on the metering pump in figs 1-2,5, para 0019-0027).
Regarding claim 10, Valego discloses, wherein determining the user input signal is a lockout access code comprises determining whether a user input is actuated continuously by contact with a user for a specified duration of time (determining lockout signal by determining on or more pushbutton depressed and held for predetermined interval of time in abstract, para 0020-0026).
Regarding claim 11, Valego discloses wherein the specified duration of time is at least 4 seconds (four seconds in fig 5 blocks 129,143 and para 0020-0022).
Regarding claim 12, Valego discloses wherein the specified duration of time is between 4 seconds and 10 seconds (four seconds in fig 5 blocks 129,143 and para 0020-0022).
Regarding claim 13, Valego discloses wherein determining the user input signal is a lockout access code comprises determining two or more input stations of the user interface are actuated simultaneously and continuously for a specified duration of time (determining lockout signal by determining more than one lockout pushbutton depressed and held for predetermined interval of time in para 0024).
Regarding claim 14, wherein the specified duration of time is between 4 seconds and 10 seconds (four seconds in fig 5 blocks 129,143 and para 0020-0022).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Borras (US 4843385) discloses a communication device with keypad lock. Hendrixson (US 2009/0005729) and Kidd (US 2010/0308963) disclose pumps with interface/ keypad lockout.
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/OMEED ALIZADA/ Primary Examiner, Art Unit 2686
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