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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-13) in the reply filed on 05/18/2026 is acknowledged.
Claims 14-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/20/2024 and 03/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 3-5,and 7 are objected to because of the following informalities: the hyphen from the word “de-activated/de-activation” should be removed. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 is directed to both product and a process. A single claim that claims both an apparatus and the method steps of using the apparatus. Claim 1 is to an apparatus, i.e. a product, and claim 1 also requires specific method steps of “a neurostimulation device for controllably delivering a neural stimulus”. Examiner suggest amending to recite the limitation “a neurostimulation device configured for controllably delivering a neural stimulus”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“control unit” in claim 1 fails to recite sufficient structure. [0065] of the instant specification discloses the processor as the structure, and will be interpreted as such.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the switch controls" in line 15 and 18. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “a plurality of switch controls”.
Claim 3-5 recites the limitation "the control tiles" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2 only recites 1 “tile control”.
Claim 3-5 recites the limitation "the associated control switch" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2 recites in association with each switch, so there is not 1 associated control switch, but multiple associated control switches.
Regarding claim 5, it is unclear if the “one of the tile controls” of line 3, is the same or different than the “one of the tile controls” of line 7.
Claim 6 recites the limitation "the appearance" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "each tile control" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 2 requires 1 tile control.
Claim 7 recites the limitation "each tile control" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 2 requires 1 tile control.
Claim 8 recites the limitation "the appearance" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, the phrase “each activated switch control” lacks sufficient antecedent basis because claim 1 requires the activation of one of the switch controls, and not each.
Claim 10 recites the limitation "the ramping value" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the ramping value" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the down-ramping value" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the down-ramping value" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al. (US 20200323462)(Hereinafter Jiang).
Regarding claim 1, Jiang teaches A neurostimulation system ([0004] “Treatments with implantable neurostimulation systems”) comprising:
a neurostimulation device for controllably delivering a neural stimulus (Fig. 1 (IPG 50) and Fig. 4), the neurostimulation device comprising:
a stimulus source configured to deliver neural stimuli via one or more stimulus electrodes of a plurality of implanted electrodes to a neural pathway of a patient ([0077] “the pulse generator can generate one or more non-ablative electrical pulses that are delivered to a nerve to control pain or cause some other desired effect, for example to inhibit, prevent, or disrupt neural activity for the treatment of OAB or bladder related dysfunction.” [0074] “implantable system 100 includes an IPG 10 that is coupled to a neurostimulation lead 20 that includes a group of neurostimulation electrodes 40 at a distal end of the lead.”); and
a control unit configured to control the stimulus source to deliver the neural stimuli according to a stimulus intensity parameter ([0077] “One or more of the pulse generators can include a processor and/or memory adapted to provide instructions to and receive information from the other components of the implantable neurostimulation system.” [0078] “One or more properties of the electrical pulses can be controlled via a controller of the IPG or EPG. In some embodiments, these properties can include, for example, the frequency, amplitude, pattern, duration, or other aspects of the timing and magnitude of the electrical pulses… the IPG 100 includes a controller having one or more pulse programs, plans, or patterns that may be created and/or pre-programmed.”); and
an external computing device in communication with the neurostimulation device (Fig. 1 (clinician programmer/external computing device 60 communicatively connected to IPG 50)), the external computing device comprising:
a display configured to receive user interactions ([0087] “The CP 60 includes a communication module, a stimulation module and an EMG sensing module. The communication module communicates with the IPG and/or EPG in the medical implant communication service frequency band for programming the IPG and/or EPG. While this configuration reflects a portable user interface display device, such as a tablet computer, it is appreciated that the CP may be incorporated into various other types of computing devices, such as a laptop, desktop computer, or a standalone terminal for use in a medical facility.”), and
a processor ([0063] “the CP 60 has a control unit which can include a microprocessor and specialized computer-code instructions for implementing methods and systems for use by a physician in deploying the treatment system and setting up treatment parameters.”) configured to:
render a plurality of switch controls on the display, each switch control corresponding to a predetermined stimulus electrode configuration of the one or more stimulus electrodes (Fig. 8A3 with 4 electrode configuration recommendations. See selected configurations by user in Fig. 20C-J, via the box surrounding the selected configuration.);
instruct, on receiving an activation of one of the switch controls by a user, the control unit to control the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration ([0127] “After identification of the electrode configuration recommendations, the system presents the electrode configuration recommendations to the physician, typically on a user interface of the CP such as shown in FIG. 18, on which the physician may select any of the electrode configurations for testing, modify a recommended electrode configuration as desired, or create a new electrode configuration.” Fig. 8A3 where a selected electrode configuration delivers stimulus by adjusting amplitudes and testing comfort levels.); and
instruct, on receiving a de-activation of one of the switch controls by a user, the control unit to control the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration (Fig. 20K “End Session” User selects the end session, as noted with the cursor on the GUI. 64 is the selected electrode configuration of the session for Fig. 20K.).
Regarding claim 2, Jiang teaches wherein the processor is further configured to render, in association with each switch control, a tile control (Fig. 20C-J, Fig. 20F shows ability the frequency tile that can be controlled to increase or decrease parameter values.).
Regarding claim 3, Jiang teaches wherein the processor is further configured to: de-activate, on receiving an activation of one of the tile controls by a user while the associated switch control is activated, the associated switch control, thereby causing the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration (Fig. 20K “End Session” User selects the end session, as noted with the cursor on the GUI, which Examiner interprets as one of the tile controls. 64 is the selected electrode configuration of the session for Fig. 20K that is occurring when the “End session” is selected.).
Regarding claim 4, Jiang teaches wherein the processor is further configured to: activate, on receiving a de-activation of one of the tile controls by a user while the associated switch control is de-activated, the associated switch control, thereby causing the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration (See Fig. 20C-D where the “Electrode Recommendation” tile has different electrode configuration, which is activated via the selection of the electrode configuration, by the physician. Stimulation is also applied, see dial 66 where stimulation is applied at 4.1 mA. Examiner notes that the 1st configuration is de-activated from Fig. 20C to Fig. 20D, where the control switch is de-activated in the 1st electrode configuration in Fig. 20D which is received by the user because the 3rd configuration is selected. This also means that the 3rd configuration is de-activated, until the control switch is activated for the 3rd configuration in Fig. 20D, thereby delivering the stimuli.).
Regarding claim 5, Jiang teaches wherein the processor is further configured to:
activate, on receiving an activation of one of the tile controls by a user while the associated switch control is de-activated, the associated switch control, thereby causing the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration (See Fig. 20C-D where the “Electrode Recommendation” tile has different electrode configuration, which is activated via the selection of the electrode configuration, by the physician. Stimulation is also applied, see dial 66 where stimulation is applied at 4.1 mA. See Fig. 20B, prior to reaching the programming stage, where the control switch is not on the screen, and thereby de-activated, and then the programming screen is reached via the activation/clicking of the tile control “Programming”.); and
de-activate, on receiving a de-activation of one of the tile controls by a user while the associated switch control is activated, the associated switch control, thereby causing the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration (Fig. 20K “End Session” User selects the end session, as noted with the cursor on the GUI, which Examiner interprets as one of the tile controls. 64 is the selected electrode configuration of the session for Fig. 20K that is occurring when the “End session” is selected.).
Regarding claim 6, Jiang teaches wherein the processor is configured to alter the appearance of each tile control depending on its state of activation (See Fig. 20I-J showing 20 Hz, whereas Fig. 20G-H showing 25 Hz, which is an alter in appearance.).
Regarding claim 8, Jiang teaches wherein the processor is configured to alter the appearance of each switch control depending on its state of activation (Compare Fig. 20G where the electrode configuration box is different than the configuration box of Fig. 20H, which is an alteration of an appearance, as the state of activation of the electrode configuration has changed.).
Regarding claim 9, Jiang teaches wherein the processor is configured to record, upon activation by a user of a further control rendered on the display, the predetermined stimulus electrode configuration corresponding to each activated switch control (Fig. 18 where the electrode configuration and parameters are saved/recorded.).
Regarding claim 10, Jiang teaches wherein the processor is configured to instruct the control unit to control the stimulus source to deliver the neural stimuli by:
ramping a value of the stimulus intensity parameter while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the ramping value of the stimulus intensity parameter (Fig. 6B ramp-up duration. Stimulus source must still be delivering stimuli as the pulse is shown during ramp up.).
Regarding claim 12, Jiang teaches wherein the processor is configured to instruct the control unit to control the stimulus source to cease delivering the neural stimuli by:
ramping down a value of the stimulus intensity parameter while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter (Fig. 6B ramp-down duration. Stimulus source must still be delivering stimuli as the pulse is shown during ramp down.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 20200323462)(Hereinafter Jiang) in view of Yoo (US 2019/0001135)(IDS)(Hereinafter Yoo).
Regarding claim 11, Jiang teaches the invention of claim 1. Jiang does not teach teaches the ramping value of the stimulus intensity parameter traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold. Yoo, in the same field of endeavor, teaches the neurostimulation of the nerve for observing a user response (Abstract), and further teaches wherein the ramping value of the stimulus intensity parameter traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold ([0182] “as the intensity moves into a range normally associated with user discomfort, the rate of intensity growth can be lower 503b so that the increase in intensity does not rise too quickly. Accordingly the rise function can be linear, geometric, asymptotic, or discontinuous and multi-sloped 503a,b,c where changes in slope occur a predefined intensities or due to user input.” See Fig. 10A where, if the derivative of the parabolic signal is obtained, one skilled in the art or any calculus student would be able to determine that the rate of change above the discomfort threshold is lower than the rate of change of the signal below the discomfort threshold. Examiner notes that the limitation is describing a non-linear ramping.
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) to experiment to find the pain threshold of a user ([0182]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Jiang, with the ramping value of the stimulus intensity parameter traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold of Yoo, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 13, Jiang teaches the invention of claim 1. Jiang does not teach teaches the down-ramping value of the stimulus intensity parameter traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold. Yoo, in the same field of endeavor, teaches the neurostimulation of the nerve for observing a user response (Abstract), and further teaches wherein the down-ramping value of the stimulus intensity parameter traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold ([0182] “as the intensity moves into a range normally associated with user discomfort, the rate of intensity growth can be lower 503b so that the increase in intensity does not rise too quickly. Accordingly the rise function can be linear, geometric, asymptotic, or discontinuous and multi-sloped 503a,b,c where changes in slope occur a predefined intensities or due to user input.” See Fig. 10A where, if the derivative of the parabolic signal is obtained, one skilled in the art or any calculus student would be able to determine that the rate of change above the discomfort threshold is lower than the rate of change of the signal below the discomfort threshold. Examiner notes that the limitation is describing a non-linear ramping.
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) to experiment to find the pain threshold of a user ([0182]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Jiang, with the down-ramping value of the stimulus intensity parameter traverses stimulus intensities below a predetermined threshold at a faster rate than stimulus intensities above the predetermined threshold of Yoo, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 20200323462)(Hereinafter Jiang) in view of Yoo (US 2019/0001135)(IDS)(Hereinafter Yoo) and Thacker (US 9,295,840)(Hereinafter Thacker).
Regarding claim 7, Jiang teaches the invention of claim 1. Jiang does not teach teaches become activated upon the user interacting with the tile control. Yoo, in the same field of endeavor, teaches the neurostimulation of the nerve for observing a user response (Abstract), and further teaches wherein each tile control is configured to:
become activated upon the user interacting with the tile control ([0065] “The user interface module 44, provides at least one user control for allowing adjustment of therapy (e.g. turning therapy on/off or increasing/decreasing stimulation intensity). As disclosed, in embodiments, control signals provided by a user in the form of gestures, voice commands, are used to control device operation.”) to control the device when needed ([0065]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Jiang, with the become activated upon the user interacting with the tile control of Yoo, because such a modification would allow to control the device when needed.
However, Jiang in view of Yoo does not teach remain activated as long as the user continues to interact with the tile control; and become de-activated as soon as the user ceases to interact with the tile control. Note the continued interaction is interpreted as a constant interaction (such as holding a button) necessary to prevent deactivation, such as discussed in the instant specification (Yoo [0088]). Thacker, in the same field of endeavor of controlling an implantable electrical stimulation (Col 1, Lines 20-25), teaches remain activated as long as the user continues to interact with the tile control; and become de-activated as soon as the user ceases to interact with the tile control (Col 10, Lines 46-54: "In the clinic and/or during a trial period, many or all of the expected locations/
amplitudes to be used can be tested for sensation thresholds and patient tolerance. This can be done
with an automated 50 system that is directed by the patient, where the patient holds a button to let
the test proceed and then releases the button if they feel any sensation (stopping the test for that
location). The test cycles through the amplitudes/frequency/pulse width as needed for each
location"). 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 Yoo's button push to signify a threshold has been reached with the
button hold until a threshold is reached in Thacker. At the time, there would have been a recognized
need to determine a sensation threshold based on user-supplied feedback via a button, such as that
used in Yoo. Given the limited options for manipulating a button, the button hold until a threshold is
reached in Thacker would have been a known calibration option and obvious to try. A person of ordinary
skill in the art would have a reasonable expectation of successfully using the button hold until reaching a
threshold calibration in Thacker as part of the control mechanism in Yoo.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 12 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 of copending Application No. 18/722,972 in view of Jiang et al. (US 20200323462)(Hereinafter Jiang).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘972 teaches A neurostimulation system (Claim 1 “A neurostimulation system”) comprising:
a neurostimulation device for controllably delivering a neural stimulus (Claim 1 “a neurostimulation device for controllably delivering neural stimuli”), the neurostimulation device comprising:
a stimulus source configured to deliver neural stimuli via one or more stimulus electrodes of a plurality of implanted electrodes to a neural pathway of a patient (claim 1 “a stimulus source configured to deliver neural stimuli via selected electrodes of a plurality of implantable electrodes to a neural pathway of a patient”); and
a control unit configured to control the stimulus source to deliver the neural stimuli according to a stimulus intensity parameter (claim 1 “a control unit configured to control the stimulus source to deliver each neural stimulus according to a stimulus intensity parameter”); and
an external computing device in communication with the neurostimulation device (claim 1 “an external computing device in communication with the neurostimulation device”), the external computing device comprising:
a display configured to receive user interactions (claim 1 “a display”), and
a processor (claim 1 “a processor”).
However, ‘972 does not teach render a plurality of switch controls on the display, each switch control corresponding to a predetermined stimulus electrode configuration of the one or more stimulus electrodes, instruct, on receiving an activation of one of the switch controls by a user, the control unit to control the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration, and instruct, on receiving a de-activation of one of the switch controls by a user, the control unit to control the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration. Jiang, in the same field of endeavor, teaches an IPG electrically couple to a GUI for displaying different treatment configuration for physicians to select (Abstract), and further teaches render a plurality of switch controls on the display, each switch control corresponding to a predetermined stimulus electrode configuration of the one or more stimulus electrodes (Fig. 8A3 with 4 electrode configuration recommendations. See selected configurations by user in Fig. 20C-J, via the box surrounding the selected configuration.);
instruct, on receiving an activation of one of the switch controls by a user, the control unit to control the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration ([0127] “After identification of the electrode configuration recommendations, the system presents the electrode configuration recommendations to the physician, typically on a user interface of the CP such as shown in FIG. 18, on which the physician may select any of the electrode configurations for testing, modify a recommended electrode configuration as desired, or create a new electrode configuration.” Fig. 8A3 where a selected electrode configuration delivers stimulus by adjusting amplitudes and testing comfort levels.); and
instruct, on receiving a de-activation of one of the switch controls by a user, the control unit to control the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration (Fig. 20K “End Session” User selects the end session, as noted with the cursor on the GUI. 64 is the selected electrode configuration of the session for Fig. 20K.) to optimize the best selection for the given treatment ([0126]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of ‘972, with the render a plurality of switch controls on the display, each switch control corresponding to a predetermined stimulus electrode configuration of the one or more stimulus electrodes, instruct, on receiving an activation of one of the switch controls by a user, the control unit to control the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration, and instruct, on receiving a de-activation of one of the switch controls by a user, the control unit to control the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration of Jiang, because such a modification would allow to optimize the best selection for the given treatment.
Regarding claim 12, ‘972 teaches wherein the processor is configured to instruct the control unit to control the stimulus source to cease delivering the neural stimuli by:
ramping down a value of the stimulus intensity parameter while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter (claim 2 “wherein the processor is further configured to ramp down, upon receiving the de-activation, the value of the stimulus intensity parameter, while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter.”).
Claims 1 and 12 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 of copending Application No. 19/288,312 in view of Jiang et al. (US 20200323462)(Hereinafter Jiang).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘312 teaches A neurostimulation system (Claim 1 “A neurostimulation system”) comprising:
a neurostimulation device for controllably delivering a neural stimulus (Claim 1 “a neurostimulation device for controllably delivering neural stimuli”), the neurostimulation device comprising:
a stimulus source configured to deliver neural stimuli via one or more stimulus electrodes of a plurality of implanted electrodes to a neural pathway of a patient (claim 1 “a stimulus source configured to deliver neural stimuli via selected electrodes of a plurality of implantable electrodes to a neural pathway of a patient”); and
a control unit configured to control the stimulus source to deliver the neural stimuli according to a stimulus intensity parameter (claim 1 “a control unit configured to control the stimulus source to deliver each neural stimulus according to a stimulus intensity parameter”); and
an external computing device in communication with the neurostimulation device (claim 1 “an external computing device in communication with the neurostimulation device”), the external computing device comprising:
a display configured to receive user interactions (claim 1 “a display”), and
a processor (claim 1 “a processor”).
However, ‘312 does not teach render a plurality of switch controls on the display, each switch control corresponding to a predetermined stimulus electrode configuration of the one or more stimulus electrodes, instruct, on receiving an activation of one of the switch controls by a user, the control unit to control the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration, and instruct, on receiving a de-activation of one of the switch controls by a user, the control unit to control the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration. Jiang, in the same field of endeavor, teaches an IPG electrically couple to a GUI for displaying different treatment configuration for physicians to select (Abstract), and further teaches render a plurality of switch controls on the display, each switch control corresponding to a predetermined stimulus electrode configuration of the one or more stimulus electrodes (Fig. 8A3 with 4 electrode configuration recommendations. See selected configurations by user in Fig. 20C-J, via the box surrounding the selected configuration.);
instruct, on receiving an activation of one of the switch controls by a user, the control unit to control the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration ([0127] “After identification of the electrode configuration recommendations, the system presents the electrode configuration recommendations to the physician, typically on a user interface of the CP such as shown in FIG. 18, on which the physician may select any of the electrode configurations for testing, modify a recommended electrode configuration as desired, or create a new electrode configuration.” Fig. 8A3 where a selected electrode configuration delivers stimulus by adjusting amplitudes and testing comfort levels.); and
instruct, on receiving a de-activation of one of the switch controls by a user, the control unit to control the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration (Fig. 20K “End Session” User selects the end session, as noted with the cursor on the GUI. 64 is the selected electrode configuration of the session for Fig. 20K.) to optimize the best selection for the given treatment ([0126]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of ‘312, with the render a plurality of switch controls on the display, each switch control corresponding to a predetermined stimulus electrode configuration of the one or more stimulus electrodes, instruct, on receiving an activation of one of the switch controls by a user, the control unit to control the stimulus source to deliver the neural stimuli via the corresponding predetermined stimulus electrode configuration, and instruct, on receiving a de-activation of one of the switch controls by a user, the control unit to control the stimulus source to cease delivering the neural stimuli via the corresponding predetermined stimulus electrode configuration of Jiang, because such a modification would allow to optimize the best selection for the given treatment.
Regarding claim 12, ‘312 teaches wherein the processor is configured to instruct the control unit to control the stimulus source to cease delivering the neural stimuli by:
ramping down a value of the stimulus intensity parameter while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter (claim 2 “wherein the processor is further configured to ramp down, upon receiving the de-activation, the value of the stimulus intensity parameter, while instructing the control unit to control the stimulus source to deliver the neural stimuli according to the down-ramping value of the stimulus intensity parameter.”).
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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