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 .
Status of Claims
Claims 1-20 are currently pending and under examination.
Response to Arguments
Applicant’s arguments, see Remarks pages 6-11, (Rejections Over the Prior Art), filed 10/23/2025, with respect to the 35 U.S.C. § 102 and 35 U.S.C. § 103 rejections of claims 1-20 have been fully considered. Applicant argues:
Turney seeks to set "inequality constraints" for his parameters. [44]. For example, because moving slider 60 upwards will also move slider 62 upwards when 60 contacts 62, the parameter set by slider 62 is always greater than the parameter set by slider 60. In short hand, 62 > 60.
But this is not what Applicant claims. Applicant claims that:
when one of the stimulation parameters is adjusted within its range to a value, the control circuitry is configured to automatically constrain the ranges within which the other stimulation parameters can be adjusted is in accordance with the model and the value (claim 1)
adjusting one of the stimulation parameters within its range to a value; and automatically constraining the ranges within which the other stimulation parameters can be adjusted in accordance with the model and the value (claim 11).
Moving slider 60 upwards "preserv[es] the inequality constraint," [0044], that 62 > 60. But this doesn't "constrain[] the ranges within which the other stimulation parameters can be adjusted." Adjusting 60 doesn't limit adjusting 62 at all. Slider 62 can still be adjusted along its full range. It can for example be lowered (pushed downwards), and when doing so, it may also eventually lower slider 60 when they contact. Again, this constrains 62 > 60, but does not "constrain the ranges within which the other stimulation parameters can be adjusted." Again, both 60 and 62 remain unconstrained and are freely adjustable in Turney's system.
This is true of all other parameters and sliders in Turney: while there may be a relationship between the various parameters, adjusting one parameter does not constrain a range of adjustment of any parameter. (page 11, 10/23/2025 Remarks)
This argument is not persuasive. The Examiner interprets the Applicant as arguing the use of the term “constrain” as requiring both (1) adjusting a parameter within a range which further limits a range of another parameter and (2) preventing parameters from being adjusted outside those ranges. As explained by the Applicant (pages 6-7, 10/23/2025 Remarks), the Examiner notes the instant specification at [00221] and Fig. 33B discuss/show a mechanism for preventing parameters from being adjusted outside a range (such as the exclusion zones 1010).
However, Turney (US PG Pub 2003/0125776 A1) uses the term “constrain” when describing how the adjustment of one parameter provides a limitation on another parameter ([0044-0048] – e.g. “Thus, in accordance to FIGS. 4B and 4C, changing the constraint value causes constraining values to change. Specifically, as shown in FIGS. 4B and 4C, a change in slider 60 results in changes that affect the related sliders” in [0044]). The purpose of Turney’s device is described as preventing a user from entering settings which violate a constraint ([0010] - “The present invention provides apparatus and method to show a user interactive relationship between constraints, and prevent the user from entering values that may violate the constraints. In a preferred embodiment, a mechanical method implementing sliders to display the interdependency of parameters based on the governing constraints is used”). Lacking any further details in the claim language or an explicit definition of the term “constrain” in the instant specification, the broadest reasonable interpretation (BRI) of the term “constrain” would support the inclusion of the constraint in Turney as a type of constraint based on the term’s usage within the claim language (see MPEP 2111.01). Therefore, the rejections of claims 1-20 are maintained.
Additionally, it should also be noted that, upon further inspection, previously presented prior art Cerny 2016 (US PG Pub 2016/0246935 A1) teaches graphical elements which can be adjusted (Figs. 5A-5D, [0084-0085] – circular control elements are used to control the parameters and integrated into the overall interface, such as seen in Fig. 7) where the upper achievable limit or maximum value for a parameter is prevented from being adjusted above a limit by a locking mechanism ([0086]). Cerny 2016 also teaches the “upper achievable value (which may also be referred to as a ‘maximum achievable value’) may vary based on other parameters set with respect to the corresponding medical device” ([0086]). This would be considered another instance of a type of constraint covered by the BRI of the term “constrain.”
Summary: The prior art rejections for claims 1-20 are maintained.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 11, and 13 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Turney (US PG Pub 2003/0125776 A1, see previously cited).
Regarding Claim 1, Turney discloses a system for controlling an implantable medical device of a patient ([0023] – the control scheme can be used for controlling many types of implantable stimulators, Fig. 1, [0022] – example of a pacemaker provided), comprising:
-a first external device configured to program the implantable stimulator device ([0024] – external programming unit 20) comprising:
-a graphical user interface ([0012] – adjustable sliders on a display for controlling settings);
and control circuitry configured ([0025] – discloses processor) to:
•receive a model comprising a plurality of sets of stimulation parameters developed for the patient ([0048] – the software package maintains the ability to contain multiple sets of sliders based on the application), each of the sets of stimulation parameters being executable by the implantable stimulator device to provide stimulation to the patient ([0043] – the parameters control the stimulation pattern for a pacemaker)
•provide on the graphical user interface an adjustment for each of the stimulation parameters (Fig 4A-4C, [0043-0044] – virtual sliders allowing for adjustments of different parameters), wherein a range within which each stimulation parameter can be adjusted is automatically constrained by the model ([0044] – adjusting one parameter constrains the ranges of other related parameters: “Thus, in accordance to FIGS. 4B and 4C, changing the constraint value causes constraining values to change. Specifically, as shown in FIGS. 4B and 4C, a change in slider 60 results in changes that affect the related sliders”)
•wherein when one of the stimulation parameters is adjusted within its range to a value (Fig 4A-4C, [0043-0044] – virtual sliders allowing for adjustments of different parameters), the control circuitry is configured to automatically constrain the ranges within which the other stimulation parameters can be adjusted in accordance with the model and the value ([0044] – adjusting one parameter constrains the ranges of other related parameters: “Thus, in accordance to FIGS. 4B and 4C, changing the constraint value causes the values of other parameters to change. Specifically, as shown in FIGS. 4B and 4C, a change in slider 60 results in changes that affect the related sliders”; [0048] –
“The sliders are also implemented to constrain one another based on a software system that maintains the constraining relationship within a given set of sliders. These sliders, unlike other user interface sliders include extensions that constrain the movement of other sliders that are related
therewith”).
The purpose of Turney’s device is described as preventing a user from entering settings which violate a constraint ([0010] - “The present invention provides apparatus and method to show a user interactive relationship between constraints, and prevent the user from entering values that may violate the constraints. In a preferred embodiment, a mechanical method implementing sliders to display the interdependency of parameters based on the governing constraints is used”). Lacking any further details in the claim language or an explicit definition of the term “constrain” in the instant specification, the broadest reasonable interpretation (BRI) of the term “constrain” would support the inclusion of the constraint in Turney as a type of constraint based on the term’s usage within the claim language (see MPEP 2111.01).
Therefore, Claim 1 is anticipated by Turney.
Regarding Claim 3, Turney anticipates the system for controlling an implantable medical device according to Claim 1, as indicated hereinabove. Turney further discloses the first external device comprises a clinician programmer ([0041] – “In addition, these event-indicating signals may be communicated, via uplink transmission, to external programming unit 20 for visual display to a physician or clinician”).
Therefore, Claim 3 is anticipated by Turney.
Regarding Claim 11, Turney discloses a method for controlling an implantable medical device of a patient ([0010]), comprising:
•providing a model at a first external device, wherein the model comprises a plurality of sets of stimulation parameters developed for the patient ([0048] – the software package maintains the ability to contain multiple sets of sliders based on the application), each of the sets of stimulation parameters being executable by the implantable stimulator device to provide stimulation to the patient ([0043] – the parameters control the stimulation pattern for a pacemaker)
•providing on a graphical user interface of the first external device an adjustment for each of the stimulation parameters (Fig 4A-4C, [0043-0044] – virtual sliders allowing for adjustments of different parameters), wherein a range within which each stimulation parameter can be adjusted is automatically constrained by the model ([0044] – adjusting one parameter constrains the ranges of other related parameters: “Thus, in accordance to FIGS. 4B and 4C, changing the constraint value causes constraining values to change. Specifically, as shown in FIGS. 4B and 4C, a change in slider 60 results in changes that affect the related sliders”);
• adjusting one of the stimulation parameters within its range to a value (Fig 4A-4C, [0043-0044] – virtual sliders allowing for adjustments of different parameters); and
• automatically constraining the ranges within which the other stimulation parameters can be adjusted in accordance with the model ([0044] – adjusting one parameter constrains the ranges of other related parameters: “Thus, in accordance to FIGS. 4B and 4C, changing the constraint value causes constraining values to change. Specifically, as shown in FIGS. 4B and 4C, a change in slider 60 results in changes that affect the related sliders”; [0048] – “The sliders are also implemented to constrain one another based on a software system that maintains the constraining relationship within a given set of sliders. These sliders, unlike other user interface sliders include extensions that constrain the movement of other sliders that are related therewith”).
The purpose of Turney’s device is described as preventing a user from entering settings which violate a constraint ([0010] - “The present invention provides apparatus and method to show a user interactive relationship between constraints, and prevent the user from entering values that may violate the constraints. In a preferred embodiment, a mechanical method implementing sliders to display the interdependency of parameters based on the governing constraints is used”). Lacking any further details in the claim language or an explicit definition of the term “constrain” in the instant specification, the broadest reasonable interpretation (BRI) of the term “constrain” would support the inclusion of the constraint in Turney as a type of constraint based on the term’s usage within the claim language (see MPEP 2111.01).
Therefore, Claim 11 is anticipated by Turney.
Regarding Claim 13, Turney anticipates the method for controlling an implantable medical device according to Claim 11, as indicated hereinabove. Turney further discloses the first external device comprises a clinician programmer ([0041] – “In addition, these event-indicating signals may be communicated, via uplink transmission, to external programming unit 20 for visual display to a physician or clinician”).
Therefore, Claim 13 is anticipated by Turney.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 2, 4-5, 7, 12, 14-15, and 17 are rejected under U.S.C 103 as being unpatentable over Turney (US PG Pub 2003/0125776 A1, see previously cited), in view of Cerny (US PG Pub 2016/0246935 A1, see previously cited), to be referred to as Cerny 2016.
Regarding Claim 2, Turney anticipates the system for controlling an implantable medical device according to Claim 1, as indicated hereinabove. Turney discloses an external programming unit used by a clinician ([0041]). Turney states: “Although the present invention will be described herein in one embodiment which includes a pacemaker, those of ordinary skill in the art having the benefit of the present disclosure will appreciate that the present invention may be advantageously practiced in connection with numerous other types of implantable medical device systems, and indeed in any application in which it is desirable to provide a communication link between two physically separated components, such as may occur during transtelephonic monitoring” ([0023]). However, Turney does not disclose the first external device comprises a patient remote controller.
Cerny 2016, in the same field of endeavor of programmable medical devices ([0002]) to deliver stimulation therapy ([0023]), teaches definitively separate patient and clinician controllers ([0038] – “Programmer 24 may also be configured for use by patient 12A. When configured as a patient programmer, programmer 24 may have limited functionality (compared to a clinician programmer) in order to prevent patient 12A from altering critical functions of IMD 324 or applications that may be detrimental to patient 12A. In this manner, programmer 24 may only allow patient 12A to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation apparatus with a graphical interface for adjusting settings by incorporating the programmable patient controller in Cerny 2016. This would have been obvious because both Turney and Cerny 2016 discuss a programmable clinician controller and Cerny 2016 provides a solution/improvement by providing greater flexibility with a patient controller which allows for limited settings adjustments by the patient outside of a clinician programming session. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Turney by incorporating the programmable patient controller in Cerny 2016.
Therefore, Claim 2 is obvious over Turney in view of Cerny 2016.
Regarding Claim 4, Turney anticipates the system for controlling an implantable medical device according to Claim 1, as indicated hereinabove. Turney discloses stimulation parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose the stimulation parameters comprise a stimulation amplitude, pulse width, and frequency.
Cerny 2016, in the same field of endeavor of programmable medical devices ([0002]) to deliver stimulation therapy ([0023]), teaches the setting of pulse amplitudes, pulse widths, and pulse frequency for a signal generator ([0037]). A variety of control features for adjusting parameters, including sliders, are described ([0101]), where such adjustment mechanisms are designed with the intention of limiting selectable values within a range ([0086]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation apparatus with a graphical interface for adjusting stimulation waveform settings by incorporating the amplitude, pulse width, and pulse rate as parameters in Cerny 2016. This would have been obvious because both Turney and Cerny 2016 discuss programmable waveforms and Cerny 2016 provides a solution/improvement by defining the stimulation parameters in terms of overall amplitude, pulse width, and pulse frequency as the most general features of a waveform (compared with the more specific waveform parameters in Turney). Amplitude, pulse width, and pulse frequency are interrelated by virtue of describing a shared waveform and could be dynamically adjusted based on a model. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Turney by incorporating the amplitude, pulse width, and pulse rate as parameters in Cerny 2016.
Therefore, Claim 4 is obvious over Turney in view of Cerny 2016.
Regarding Claim 5, the system for controlling an implantable medical device according to Claim 4 is obvious over Turney in view of Cerny 2016, as indicated hereinabove. Turney discloses stimulation pacing parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose the one of the stimulation parameters comprises the frequency, and wherein the other of the stimulation parameters comprises the pulse width and the amplitude.
Cerny 2016, in the same field of endeavor of programmable medical devices ([0002]) to deliver stimulation therapy ([0023]), teaches the setting of pulse amplitudes, pulse widths, and pulse frequency for a signal generator ([0037]). A variety of control features for adjusting parameters, including sliders, are described ([0101]), where such adjustment mechanisms are designed with the intention of limiting selectable values within a range ([0086]). Given the pulse amplitudes, pulse widths, and pulse frequency describe the same stimulation waveform, changing one parameter such as frequency would necessarily alter the achievable values for other waveform parameters, especially in view of safety limits.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation apparatus with a graphical interface for adjusting stimulation waveform settings by incorporating the amplitude, pulse width, and pulse rate as parameters in Cerny 2016. This would have been obvious because both Turney and Cerny 2016 discuss programmable waveforms and Cerny 2016 provides a solution/improvement by defining the stimulation parameters in terms of overall amplitude, pulse width, and pulse frequency as the most general features of a waveform (compared with the more specific waveform parameters in Turney). Amplitude, pulse width, and pulse frequency are interrelated by virtue of describing a shared waveform and could be dynamically adjusted based on a model. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Turney by incorporating the amplitude, pulse width, and pulse rate as parameters in Cerny 2016.
Therefore, Claim 5 is obvious over Turney in view of Cerny 2016.
Regarding Claim 7, Turney anticipates the system for controlling an implantable medical device according to Claim 1, as indicated hereinabove. Turney discloses the control circuitry ([0025]) is further configured to provide on the graphical user interface ([0012]) a model wherein the range within which each stimulation parameter can be adjusted is automatically further constrained by the model ([0044] – adjusting one parameter constrains the ranges of other related parameters: “Thus, in accordance to FIGS. 4B and 4C, changing the constraint value causes constraining values to change. Specifically, as shown in FIGS. 4B and 4C, a change in slider 60 results in changes that affect the related sliders”). Note the software package maintains the ability to contain multiple sets of sliders based on the application being considered ([0048]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose the mode is selectable within a menu of stimulation modes.
Cerny 2016, in the same field of endeavor of programmable medical devices ([0002]) to deliver stimulation therapy ([0023]), teaches stored programs, represented as a set of stimulation parameters, can be selected by the programmer ([0028] – “In either case, a signal generator within IMD 324 may generate the electrical stimulation therapy for DBS according to a therapy program that is selected at that given time in therapy. In examples in which IMD 324 delivers electrical stimulation in the form of stimulation pulses, a therapy program may include a set of therapy parameter values, such as a stimulation electrode combination for delivering stimulation to patient”; [0036] – “The clinician may also store therapy programs within IMD 324 with the aid of programmer 24. During a programming session, the clinician may determine one or more therapy programs that may provide efficacious therapy to patient”). Cerny 2016 teaches parameters are defined relative to a specific range within which to adjust parameter values ([0007]). When considering the programming available to the patient, ranges are able to be constrained by specific limits imposed by stored programs ([0038]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation apparatus with a graphical interface for adjusting settings by incorporating the programmable controller with a selectable stimulation program in Cerny 2016. This would have been obvious because both Turney and Cerny 2016 discuss a programmable controller defined by parameters within finite ranges and Cerny 2016 provides the ability to choose specific stored programs (parameters sets) to use during the programming session. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Turney by incorporating the programmable controller with a selectable stimulation program in Cerny 2016.
Therefore, Claim 7 is obvious over Turney in view of Cerny 2016.
Regarding Claim 12, Turney anticipates the method for controlling an implantable medical device according to Claim 11, as indicated hereinabove. Turney discloses an external programming unit used by a clinician ([0041]). Turney states: “Although the present invention will be described herein in one embodiment which includes a pacemaker, those of ordinary skill in the art having the benefit of the present disclosure will appreciate that the present invention may be advantageously practiced in connection with numerous other types of implantable medical device systems, and indeed in any application in which it is desirable to provide a communication link between two physically separated components, such as may occur during transtelephonic monitoring” ([0023]). However, Turney does not disclose the first external device comprises a patient remote controller.
Cerny 2016, in the same field of endeavor of programmable medical devices ([0002]) to deliver stimulation therapy ([0023]), teaches definitively separate patient and clinician controllers ([0038] – “Programmer 24 may also be configured for use by patient 12A. When configured as a patient programmer, programmer 24 may have limited functionality (compared to a clinician programmer) in order to prevent patient 12A from altering critical functions of IMD 324 or applications that may be detrimental to patient 12A. In this manner, programmer 24 may only allow patient 12A to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation method using a graphical interface for adjusting settings by incorporating the programmable patient controller in Cerny 2016. This would have been obvious because both Turney and Cerny 2016 discuss a programmable clinician controller and Cerny 2016 provides a solution/improvement by providing greater flexibility with a patient controller which allows for limited settings adjustments by the patient outside of a clinician programming session. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Turney by incorporating the programmable patient controller in Cerny 2016.
Therefore, Claim 12 is obvious over Turney in view of Cerny 2016.
Regarding Claim 14, Turney anticipates the method for controlling an implantable medical device according to Claim 11, as indicated hereinabove. Turney discloses stimulation parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose the stimulation parameters comprise a stimulation amplitude, pulse width, and frequency.
Cerny 2016, in the same field of endeavor of programmable medical devices ([0002]) to deliver stimulation therapy ([0023]), teaches the setting of pulse amplitudes, pulse widths, and pulse frequency for a signal generator ([0037]). A variety of control features for adjusting parameters, including sliders, are described ([0101]), where such adjustment mechanisms are designed with the intention of limiting selectable values within a range ([0086]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation method using a graphical interface for adjusting stimulation waveform settings by incorporating the amplitude, pulse width, and pulse rate as parameters in Cerny 2016. This would have been obvious because both Turney and Cerny 2016 discuss programmable waveforms and Cerny 2016 provides a solution/improvement by defining the stimulation parameters in terms of overall amplitude, pulse width, and pulse frequency as the most general features of a waveform (compared with the more specific waveform parameters in Turney). Amplitude, pulse width, and pulse frequency are interrelated by virtue of describing a shared waveform and could be dynamically adjusted based on a model. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Turney by incorporating the amplitude, pulse width, and pulse rate as parameters in Cerny 2016.
Therefore, Claim 14 is obvious over Turney in view of Cerny 2016.
Regarding Claim 15, the method for controlling an implantable medical device according to Claim 14 is obvious over Turney in view of Cerny 2016, as indicated hereinabove. Turney discloses stimulation pacing parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose the one of the stimulation parameters comprises the frequency, and wherein the other of the stimulation parameters comprises the pulse width and the amplitude.
Cerny 2016, in the same field of endeavor of programmable medical devices ([0002]) to deliver stimulation therapy ([0023]), teaches the setting of pulse amplitudes, pulse widths, and pulse frequency for a signal generator ([0037]). A variety of control features for adjusting parameters, including sliders, are described ([0101]), where such adjustment mechanisms are designed with the intention of limiting selectable values within a range ([0086]). Given the pulse amplitudes, pulse widths, and pulse frequency describe the same stimulation waveform, changing one parameter such as frequency would necessarily alter the achievable values for other waveform parameters, especially in view of safety limits.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation method using a graphical interface for adjusting stimulation waveform settings by incorporating the amplitude, pulse width, and pulse rate as parameters in Cerny 2016. This would have been obvious because both Turney and Cerny 2016 discuss programmable waveforms and Cerny 2016 provides a solution/improvement by defining the stimulation parameters in terms of overall amplitude, pulse width, and pulse frequency as the most general features of a waveform (compared with the more specific waveform parameters in Turney). Amplitude, pulse width, and pulse frequency are interrelated by virtue of describing a shared waveform and could be dynamically adjusted based on a model. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Turney by incorporating the amplitude, pulse width, and pulse rate as parameters in Cerny 2016.
Therefore, Claim 15 is obvious over Turney in view of Cerny 2016.
Regarding Claim 17, Turney anticipates the method for controlling an implantable medical device according to Claim 1, as indicated hereinabove. Turney discloses the graphical user interface further provides a model, wherein the range within which each stimulation parameter can be adjusted is automatically further constrained by the model ([0044] – adjusting one parameter constrains the ranges of other related parameters: “Thus, in accordance to FIGS. 4B and 4C, changing the constraint value causes constraining values to change. Specifically, as shown in FIGS. 4B and 4C, a change in slider 60 results in changes that affect the related sliders”). Note the software package maintains the ability to contain multiple sets of sliders based on the application being considered ([0048]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose the mode is selectable within a menu of stimulation modes.
Cerny 2016, in the same field of endeavor of programmable medical devices ([0002]) to deliver stimulation therapy ([0023]), teaches stored programs, represented as a set of stimulation parameters, can be selected by the programmer ([0028] – “In either case, a signal generator within IMD 324 may generate the electrical stimulation therapy for DBS according to a therapy program that is selected at that given time in therapy. In examples in which IMD 324 delivers electrical stimulation in the form of stimulation pulses, a therapy program may include a set of therapy parameter values, such as a stimulation electrode combination for delivering stimulation to patient”; [0036] – “The clinician may also store therapy programs within IMD 324 with the aid of programmer 24. During a programming session, the clinician may determine one or more therapy programs that may provide efficacious therapy to patient”). Cerny 2016 teaches parameters are defined relative to a specific range within which to adjust parameter values ([0007]). When considering the programming available to the patient, ranges are able to be constrained by specific limits imposed by stored programs ([0038]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation method using a graphical interface for adjusting settings by incorporating the programmable controller with a selectable stimulation program in Cerny 2016. This would have been obvious because both Turney and Cerny 2016 discuss a programmable controller defined by parameters within finite ranges and Cerny 2016 provides the ability to choose specific stored programs (parameters sets) to use during the programming session. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Turney by incorporating the programmable controller with a selectable stimulation program in Cerny 2016.
Therefore, Claim 17 is obvious over Turney in view of Cerny 2016.
Claims 6 and 16 are rejected under U.S.C 103 as being unpatentable over Turney (US PG Pub 2003/0125776 A1, see previously cited) in view of Cerny (US PG Pub 2017/0080151 A1, see previously cited), to be referred to as Cerny 2017.
Regarding Claim 6, Turney anticipates the system for controlling an implantable medical device according to Claim 1, as indicated hereinabove. Turney discloses an external programming unit used by a clinician ([0041]). Turney states: “Although the present invention will be described herein in one embodiment which includes a pacemaker, those of ordinary skill in the art having the benefit of the present disclosure will appreciate that the present invention may be advantageously practiced in connection with numerous other types of implantable medical device systems, and indeed in any application in which it is desirable to provide a communication link between two physically separated components, such as may occur during transtelephonic monitoring” ([0023]). However, Turney does not disclose a second external device, wherein the model is determined at the second external device and transmitted to the first external device.
Cerny 2017, in the same field of endeavor of programmable medical devices ([0001]) to deliver stimulation therapy ([0029]), teaches patient and clinician programmers where the patient controller is a more limited version working under the constraints imposed on the patient programmer ([0047]). The clinician programmer can directly control the function of the patient programmer ([0091] – “In addition, system 80 may allow the clinician to remotely intervene in the therapy and reprogram IMD 14, patient programmer 30, or communicate with patient 12”). The clinician programmer can “support selection and generation of programs by a clinician for use by IMD 14” ([0047]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation apparatus with a graphical interface for adjusting settings by incorporating a clinician programmer which can control the program used in the patient programmer in Cerny 2017. This would have been obvious because both Turney and Cerny 2017 discuss a programmable controller and Cerny 2017 provides a solution/improvement by allowing for multiple levels on control over the stimulation program based on the programmer’s level of training. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Turney by incorporating a clinician programmer which can control the program used in the patient programmer in Cerny 2017.
Therefore, Claim 6 is obvious over Turney in view of Cerny 2017.
Regarding Claim 16, Turney anticipates the method for controlling an implantable medical device according to Claim 11, as indicated hereinabove. Turney discloses an external programming unit used by a clinician ([0041]). Turney states: “Although the present invention will be described herein in one embodiment which includes a pacemaker, those of ordinary skill in the art having the benefit of the present disclosure will appreciate that the present invention may be advantageously practiced in connection with numerous other types of implantable medical device systems, and indeed in any application in which it is desirable to provide a communication link between two physically separated components, such as may occur during transtelephonic monitoring” ([0023]). However, Turney does not disclose determining the model at a second external device and transmitting the model to the first external device.
Cerny 2017, in the same field of endeavor of programmable medical devices ([0001]) to deliver stimulation therapy ([0029]), teaches patient and clinician programmers where the patient controller is a more limited version working under the constraints imposed on the patient programmer ([0047]). The clinician programmer can directly control the function of the patient programmer ([0091] – “In addition, system 80 may allow the clinician to remotely intervene in the therapy and reprogram IMD 14, patient programmer 30, or communicate with patient 12”). The clinician programmer can “support selection and generation of programs by a clinician for use by IMD 14” ([0047]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation method using a graphical interface for adjusting settings by incorporating a clinician programmer which can control the program used in the patient programmer in Cerny 2017. This would have been obvious because both Turney and Cerny 2017 discuss a programmable controller and Cerny 2017 provides a solution/improvement by allowing for multiple levels on control over the stimulation program based on the programmer’s level of training Therefore, a person of ordinary skill in the art would be motivated to improve the method of Turney by incorporating a clinician programmer which can control the program used in the patient programmer in Cerny 2017.
Therefore, Claim 16 is obvious over Turney in view of Cerny 2017.
Claims 8-9 and 18-19 are rejected under U.S.C 103 as being unpatentable over Turney (US PG Pub 2003/0125776 A1, see previously cited) in view of Cerny (US PG Pub 2016/0246935 A1, see previously cited), to be referred to as Cerny 2016, and Cerny (US PG Pub 2017/0080151 A1, see previously cited), to be referred to as Cerny 2017.
Regarding Claim 8, the system for controlling an implantable medical device according to Claim 7 is obvious over Turney in view of Cerny 2016, as indicated hereinabove. Turney discloses stimulation pacing parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose at least one of the stimulation modes corresponds to an activity or posture of the patient.
Cerny 2017, in the same field of endeavor of programmable medical devices ([0001]) to deliver stimulation therapy ([0029]), teaches parameters are adjusted based on postures held by the patient in order to optimize treatment efficacy ([0023] – “Changes in posture state may cause changes in efficacy due to changes in distances between electrodes or other therapy delivery elements, e.g., due to temporary migration of leads or catheters caused by forces or stresses associated with different postures, or from changes in compression of patient tissue in different posture states … To maintain therapeutic efficacy, it may be desirable to adjust therapy parameters based on different postures and/or activities engaged by the patient to maintain effective stimulation therapy. Therapy parameters may be adjusted directly or by selecting different programs or groups of programs defining different sets of therapy parameters”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation apparatus with a graphical interface for adjusting stimulation waveform settings by incorporating the changes in stimulation settings based on patient posture in Cerny 2017. This would have been obvious because both Turney and Cerny 2017 discuss programmable waveforms and Cerny 2017 provides a solution/improvement by using different modes of stimulation based on patient posture in order to address changes in stimulation due to electrode orientation. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Turney by incorporating the changes in stimulation settings based on patient posture in Cerny 2017.
Therefore, Claim 8 is obvious over Turney in view of Cerny 2016 and Cerny 2017.
Regarding Claim 9, the system for controlling an implantable medical device according to Claim 7 is obvious over Turney in view of Cerny 2016, as indicated hereinabove. Turney discloses stimulation pacing parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose at least one of the stimulation modes corresponds to stimulation having a particular feeling for the patient.
Cerny 2017, in the same field of endeavor of programmable medical devices ([0001]) to deliver stimulation therapy ([0029]), teaches parameters are adjusted in programs based on reducing pain to selected body locations ([0038] – “Each program group may support an alternative therapy selectable by patient 12, and IMD 14 may deliver therapy according to the multiple programs in a group. For example, a group may include a program directed to leg pain, a program directed to lower back pain, and a program directed to abdomen pain. In this manner, IMD 14 may treat different symptoms substantially simultaneously”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation apparatus with a graphical interface for adjusting stimulation waveform settings by incorporating the changes in stimulation settings based on producing a patient feeling in Cerny 2017. This would have been obvious because both Turney and Cerny 2017 discuss programmable waveforms and Cerny 2017 provides a solution/improvement by using different modes of stimulation based around being able to produce a pain relief response feeling to increase therapeutic reach of the device. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Turney by incorporating the changes in stimulation settings based on producing a patient feeling in Cerny 2017.
Therefore, Claim 9 is obvious over Turney in view of Cerny 2016 and Cerny 2017.
Regarding Claim 18, the method for controlling an implantable medical device according to Claim 17 is obvious over Turney in view of Cerny 2016, as indicated hereinabove. Turney discloses stimulation pacing parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose at least one of the stimulation modes corresponds to an activity or posture of the patient.
Cerny 2017, in the same field of endeavor of programmable medical devices ([0001]) to deliver stimulation therapy ([0029]), teaches parameters are adjusted based on postures held by the patient in order to optimize treatment efficacy ([0023] – “Changes in posture state may cause changes in efficacy due to changes in distances between electrodes or other therapy delivery elements, e.g., due to temporary migration of leads or catheters caused by forces or stresses associated with different postures, or from changes in compression of patient tissue in different posture states … To maintain therapeutic efficacy, it may be desirable to adjust therapy parameters based on different postures and/or activities engaged by the patient to maintain effective stimulation therapy. Therapy parameters may be adjusted directly or by selecting different programs or groups of programs defining different sets of therapy parameters”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation method using a graphical interface for adjusting stimulation waveform settings by incorporating the changes in stimulation settings based on patient posture in Cerny 2017. This would have been obvious because both Turney and Cerny 2017 discuss programmable waveforms and Cerny 2017 provides a solution/improvement by using different modes of stimulation based on patient posture in order to address changes in stimulation due to electrode orientation. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Turney by incorporating the changes in stimulation settings based on patient posture in Cerny 2017.
Therefore, Claim 18 is obvious over Turney in view of Cerny 2016 and Cerny 2017.
Regarding Claim 19, the method for controlling an implantable medical device according to Claim 17 is obvious over Turney in view of Cerny 2016, as indicated hereinabove. Turney discloses stimulation pacing parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]). However, Turney does not disclose at least one of the stimulation modes corresponds to stimulation having a particular feeling for the patient.
Cerny 2017, in the same field of endeavor of programmable medical devices ([0001]) to deliver stimulation therapy ([0029]), teaches parameters are adjusted in programs based on reducing pain to selected body locations ([0038] – “Each program group may support an alternative therapy selectable by patient 12, and IMD 14 may deliver therapy according to the multiple programs in a group. For example, a group may include a program directed to leg pain, a program directed to lower back pain, and a program directed to abdomen pain. In this manner, IMD 14 may treat different symptoms substantially simultaneously”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation method using a graphical interface for adjusting stimulation waveform settings by incorporating the changes in stimulation settings based on producing a patient feeling in Cerny 2017. This would have been obvious because both Turney and Cerny 2017 discuss programmable waveforms and Cerny 2017 provides a solution/improvement by using different modes of stimulation based around being able to produce a pain relief response feeling to increase therapeutic reach of the method. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Turney by incorporating the changes in stimulation settings based on producing a patient feeling in Cerny 2017.
Therefore, Claim 19 is obvious over Turney in view of Cerny 2016 and Cerny 2017.
Claims 10 and 20 are rejected under U.S.C 103 as being unpatentable over Turney (US PG Pub 2003/0125776 A1, see previously cited) in view of Cerny (US PG Pub 2016/0246935 A1, see previously cited), to be referred to as Cerny 2016, and Kothandaraman (US PG Pub 2014/0243925 A1, see previously cited).
Regarding Claim 10, the system for controlling an implantable medical device according to Claim 7 is obvious over Turney in view of Cerny 2016, as indicated hereinabove. Turney discloses stimulation pacing parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]) powered by a battery ([0039]). However, Turney does not disclose at least one of the stimulation modes comprises a low power mode.
Kothandaraman, in the same field of endeavor of a programmable tissue stimulation device ([0036]), teaches parameters are adjusted to minimize energy expenditure while providing an effective treatment ([0043] – “Significantly, the SCM system 10 is configured to adjust the delivered electrical modulation energy in a manner that minimizes the energy consumption required by the IPG 14 to generate the electrical modulation energy while providing efficacious therapy. The SCM system 10 may perform this optimization procedure in response to a user prompt, or may automatically initiate the optimization procedure”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation apparatus with a graphical interface for adjusting stimulation waveform settings by incorporating the power optimization mode in Kothandaraman. This would have been obvious because both Turney and Kothandaraman discuss programmable waveforms for a neuromodulation device powered by batteries and Kothandaraman provides a solution/improvement by modifying parameters to select the most efficient settings to conserve battery power. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Turney by incorporating the power optimization mode in Kothandaraman.
Therefore, Claim 10 is obvious over Turney in view of Cerny 2016 and Kothandaraman.
Regarding Claim 20, the method for controlling an implantable medical device according to Claim 17 is obvious over Turney in view of Cerny 2016, as indicated hereinabove. Turney discloses stimulation pacing parameters for the specific adjustment of cardiac pacing ([0043]). The control scheme can be used for controlling many types of implantable stimulators ([0023]) powered by a battery ([0039]). However, Turney does not disclose at least one of the stimulation modes comprises a low power mode.
Kothandaraman, in the same field of endeavor of a programmable tissue stimulation device ([0036]), teaches parameters are adjusted to minimize energy expenditure while providing an effective treatment ([0043] – “Significantly, the SCM system 10 is configured to adjust the delivered electrical modulation energy in a manner that minimizes the energy consumption required by the IPG 14 to generate the electrical modulation energy while providing efficacious therapy. The SCM system 10 may perform this optimization procedure in response to a user prompt, or may automatically initiate the optimization procedure”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Turney’s stimulation method using a graphical interface for adjusting stimulation waveform settings by incorporating the power optimization mode in Kothandaraman. This would have been obvious because both Turney and Kothandaraman discuss programmable waveforms for a neuromodulation device powered by batteries and Kothandaraman provides a solution/improvement by modifying parameters to select the most efficient settings to conserve battery power. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Turney by incorporating the power optimization mode in Kothandaraman.
Therefore, Claim 20 is obvious over Turney in view of Cerny 2016 and Kothandaraman.
Conclusions
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796