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 with traverse of Invention I and Subspecies 1A, 2A, and 3A in the reply filed on June 30, 2026 is acknowledged.
Applicant’s election with traverse of Invention I is acknowledged. The traversal of Invention I from Invention II and Invention III is on the grounds that the features relied upon for the restriction were in the dependent claims versus the independent claims. Additionally, Invention I and II share overlapping subject matter and are not mutually exclusive and that Invention III is fully commiserate with Invention I and II with no mutually different product identified. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” filed on 05/19/2026, Invention I, which encompasses claims 1-11, and Invention II, which encompasses claims 12-15, recite different features that make the inventions independent or distinct from each other. Invention III is distinct from Invention I or Invention II because it can be practiced with another materially different product, one that does not require features that Invention I and Invention II require. For these reasons, the Restriction requirement is maintained.
Applicant’s election with traverse of Subspecies 1A, 2A, and 3A is acknowledged. The traversal of Species 1-3 is on the grounds that the subspecies identified are not separately recited in the claims and that a claim that recites alternatives within its scope is a generic claim. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” the species are independent and distinct due to their mutually exclusive characteristics. In addition, a requirement for restriction is permissible if there is a patentable difference between the species as claimed and there would be a serious search and/or examination burden on the examiner if restriction is not required, see MPEP 808.01(a). For these reasons, the Election of Species requirement of Species 1-3 is maintained.
Claim Interpretation
In re claim 1, the limitation “numerical dosing value” is being interpreted as the user inputs a single value that is associated with a specific therapy setting. In this instance, the numerical dosing value corresponds to modulation magnitude which is represented by stimulation intensity. Applicant is asked to confirm or correct this interpretation.
In re claim 4, the limitation “a plurality of gain functions” is being interpreted as any function that can define a relationship between modulation magnitude and therapy parameters. Applicant is asked to confirm or correct this interpretation.
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 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone et al. (US 2009/0270947).
In re claim 1, Stone discloses a system for controlling neuromodulation therapy to a patient [0011], the system comprising:
a user-interface (UI) device configured [0039] to receive user input of
(i) a single numerical dosing value [0033] and
(ii) a correspondence between the single numerical dosing value and each of a plurality of therapy parameters ([0042]: “may store user input received through user interface into the memory”; [0045]); and
a therapy controller ([0072]: “processor of programmer”) configured to:
determine values of the plurality of therapy parameters based on the received single numerical dosing value and the correspondence ([0072]: “processor generates stimulation parameters that have a pulse width and amplitude value based on the received stimulation intensity”); and
generate a control signal to a neuromodulator to cause delivery of neuromodulation therapy to the patient in accordance with the determined values of the plurality of therapy parameters [0035].
In re claim 2, Stone discloses wherein the correspondence includes a plurality of mappings from the single numerical dosing value to each of the plurality of therapy parameters [0045, 0072].
In re claim 3, Stone discloses wherein the plurality of mappings are represented by entries of a lookup table [0045].
In re claim 4, Stone discloses wherein the plurality of mappings are represented by a plurality of gain functions ([0009]: last sentence; [0084]).
In re claim 5, Stone discloses wherein the plurality of gain functions include one or more of linear, piece-wise linear, or non-linear functions ([0068]; fig. 6; Note: the equal intensity functions showing the relationship between stimulation intensity, pulse width, and pulse amplitude are non-linear).
In re claim 6, Stone discloses further comprising a memory circuit configured to store the correspondence between the single numerical dosing value and the plurality of therapy parameters [0045].
In re claim 7, Stone discloses wherein the UI device is further configured to receive a user input to modify at least a portion of the stored correspondence between the single numerical dosing value and one or more of the plurality of therapy parameters ([0112]: “stimulation intensity value were to be change by a user”; [0113]: “the association between possible stimulation intensity values and respective equal intensity functions may… be configurable for a particular patient”);
In re claim 8, Stone discloses wherein the user input to modify at least a portion of the stored correspondence (fig 12; [0113-0115]) is based on patient physiological or functional responses to the neuromodulation therapy ([0118]: “evaluating the effect of the stimulation by monitoring physiological markers… to determine where the delivered electrical stimulation has elicited a threshold effect”).
In re claim 9, Stone discloses wherein the neuromodulation therapy includes a sub- perception therapy when the single numerical dosing value is lower than a perception threshold for inducing paresthesia in the patient ([0107]: “minimum or perceivable stimulation threshold… lowest stimulation intensity in which an effect of the stimulation is perceived by a patient”; [0118]: “in SCS, a perceivable threshold effect may include the first onset of paresthesia”; [0107]: last sentence; Note: the stimulation intensity can be set below the perceivable threshold)
In re claim 10, Stone discloses wherein the neuromodulation therapy includes a supra- perception therapy when the single numerical dosing value is higher than a perception threshold for inducing paresthesia in the patient. ([0107]: “minimum or perceivable stimulation threshold… lowest stimulation intensity in which an effect of the stimulation is perceived by a patient”; [0118]: “in SCS, a perceivable threshold effect may include the first onset of paresthesia”; [0107]: last sentence; Note: the stimulation intensity can be set above the perceivable threshold)
In re claim 11, Stone discloses wherein the neuromodulation therapy include an electrostimulation pulse train ([0011]: “delivers electrical stimulation pulses”), wherein the plurality of therapy parameters include one or more of a stimulation pulse amplitude [0037]; a stimulation pulse width [0037]; a stimulation rate [0037]; a duty cycle [0037]; a stimulation burst intensity; a stimulation pulse waveform parameter; a configuration of stimulation electrodes [0037]; or stimulation energy fractionalization among stimulation electrodes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Drew (US 2011/0172564) teaches a system that detects posture states and other related data, such as physiological data, to determine what stimulation parameters to use for electrical stimulation [0031, 0033]. A clinician can review the historical therapy information including the stimulation parameters and physiological conditions to identify issues with the therapy [0134], and user’s can provide feedback to the user interface that can be used to adjust the therapy parameters [0141].
Torgerson (US 2010/0274320) teaches a technique for programming electrical stimulation therapy intensity based on electrical charge [0010]. The user can modify the stimulation intensity and then the processor can modify the pulse amplitude and pulse width as long as they conform to the pulse amplitude/pulse width function [0070]. The function between pulse amplitude and pulse width can be linear [0058].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
Prosecution Insights