The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Objections
Claims 1 are objected to because of the following informalities:
Claim 1 is objected to because it is believed that line 8 should recite “delivering neurostimulation according to the modulated neurostimulation parameter setting.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Second Paragraph
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 1-14 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 is rejected because “the first and the second modulated neurostimulation waveforms” in lines 4-5 lacks antecedent basis. Lines 2-3 recite “a first neuromodulation parameter waveform and a second modulated neuromodulation parameter waveform”, which is distinct from what is recited in lines 4-5. It is noted that “the first and the second modulated neurostimulation waveforms” is repeated again in line 6, for which it is again unclear to what this term refers or calls back.
Claim 1 is rejected because “the modulated neurostimulation parameter setting” in the last two lines lacks antecedent basis. In lines 5-6, there is a recitation of “a modulated neurostimulation setting”, which is distinct from what is recited in the last two lines. Also, it is noted that “the neurostimulation parameter setting” appears again in claim 3.
Claims 2-14 are rejected for their dependencies upon claim 1.
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.
Claims 1-2 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al. (US Patent Pub. No. 2010/0191307)
Regarding claims 1 and 15-16, Fang discloses system and methods for producing asynchronous neural responses to treat pain and/or other patient conditions (see Title). Fang teaches a method, illustrated in Figure 5, which includes: step 571 “Select first electrical signal parameters” (see paragraph 29) and step 572 “Select second electrical signal parameters” (see 1st sentence of paragraph 30), which generally reads on the claimed “accessing a first modulated neuromodulation parameter waveform and a second modulated neuromodulation parameter waveform”. It is noted that by selecting the various parameters for steps 571 and 572, this inherently produces a signal, or waveform, that is based on the selected parameter(s), for which examples are shown in Figures 6-8. “Process portion 573 includes selecting a phase shift or offset between pulses of the first signal and pulses of the second signal” (see paragraph 30), which reads on “providing a phase offset between the first and the second modulated neurostimulation parameter waveforms to provide a modulated neurostimulation setting that includes the first and the second modulated neurostimulation waveforms and the phase offset”. “In process portion 574, the first and second electrical signals are directed to a target neural population” (see paragraph 30), which reads on the recited “delivering neurostimulation according the modulated neurostimulation parameter setting”.
Regarding claim 2, it is noted that “selecting a phase shift” is based on instructions provided by a practitioner (e.g., “an external programmer (not shown) can communicate with the implantable pulse generator 101 via electromagnetic induction. Accordingly, a practitioner can update the therapy instructions provided by the pulse generator 101” – see paragraph 23).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Lee et al. (WO 2004/096358).
Fang is described above with regard to claim 1. However, Fang does not teach the use of “objectives” for determining parameter values, including phase offsets.
Lee teaches that a “clinician may create neurostimulation therapy programs that include identified desirable electrode combinations. In some embodiments, the clinician may use the programmer to select a program, such as a program identified during a neurostimulation programming session, and direct the programmer to replicate the selected program. The programmer may change one or more parameters of the selected program, such as pulse amplitude or duty cycle, when generating the copy of the selected program. In some embodiments, the programmer may associate each of a plurality of programs identified during a neurostimulation therapy programming session with one or more program categories, and may automatically generate program groups that include two or more of the programs based on the program categories” (see Abstract). Particularly, para graph 103 states “By providing a plurality of programs that are replicated with parameters that are changed in this manner, clinician programmer 20 may allow patient 12 to select a program that addresses a current symptom level, e.g., pain level which may vary based on patient posture, activity or time of day, with a comparatively lower rate of battery consumption. In some embodiments, clinician programmer 20 may associate the selected program and the copies with respective postures, activities, times of day, symptom intensity states, or program side effect states, e.g., may label a selected program and a copy as ‘sitting’ and ‘standing,’ ‘active’ and ‘inactive,’ ‘daytime’ and ‘nighttime,’ or ‘high’ and ‘low,’ respectively.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to allow a physician to program multiple programs into an implantable pulse generator, as taught by Lee, and to include this in the system of Fang in order to allow for a patient to choose from among a plurality of preset stimulation protocols dependent upon the ailment they are currently facing. By the combination of Lee with that of Fang, it would be obvious that the various programs would include the selected phase shift of box 573, since this is a factor in the programming of the signals that are then directed to the neural population in box 574 of Fang and will affect the treatment.
Claims 4-6, 8-11, 13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Zhu (US Patent Pub. No. 2022/0184400).
Fang is described above with regard to claims 1 and 16. However, the selection and setting of the signal parameters in boxes 571 and 572 of Figure 5 are not described in detail.
Regarding claims 4 and 18, Zhu teaches a system for delivering neurostimulation that may include a programming control circuit and a user interface (see Abstract). The flowchart in Figure 14 includes steps of “At 1482, one or more parameters are selected from the one or more adjustable parameters. At 1483, one or more modulation functions are each determined for a parameter of the selected one or more parameters. At 1484, the pulse sequence is set to a modulated pulse sequence by applying the one or more modulation functions to the respective selected parameter(s) to modulate the tonic pulse sequence. In various embodiments, the modulated pulse sequence includes one or more sequence parameters each modulated by a modulation function (i.e., the one or more parameters selected from the one or more adjustable parameters)” (see paragraph 104). As shown in Figure 9, a parameter of “rate” has been selected in parameter field 962, while a sinusoidal modulation function has been selected in waveform modulation function selection field 964, with the sinusoidal function being shown in waveform modulation function visualization field 968 (see paragraph 89). Adjustable parameters field 962 illustrates four options of parameters that may be modulated, with each modulated parameter factoring into the modulated pulse sequence field 970 (see paragraph 95).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a user interface for selecting electrical signal parameters, as taught by Zhu, into the system and methods of Fang in order to provide an efficient manner for programming a stimulation device (see paragraph 4 of Fang).
Regarding claim 5, it can be seen in Figure 9 of Zhu that the modulation function is a sinusoidal function for the parameter “rate” (see waveform modulation function selection field 964 and waveform modulation function visualization field 968 of Figure 9).
Regarding claim 6, it is noted that “rate” as shown as being selected in parameter field 962 of Figure 9 of Zhu is the frequency. While the sinusoidal modulation function is selected in the waveform modulation function selection field 964 and shown in the waveform modulation function visualization field 968, the “modulated pulse sequences” in field 970 illustrates frequency modulation based on this modulated “rate”. It is also noted that within section 966, the user is able to change the both the modulation frequency and modulation depth (see paragraph 93 and Figure 9 of Zhu).
Regarding claims 8-9, Fang teaches in boxes 571 and 572 that selections are made to various electrical signal parameters, including frequency, pulse width, inter-pulse interval, burst frequency, burst width, inter-burst interval and intensity. Additionally, the combination with Zhu as described above with respect to claim 4 makes it obvious to not only set a particular value, but to set a modulation function for parameters. Therefore, the teachings of Fang and/or the combination of Fang with Zhu reads on the limitations of claim 8. The underlined parameters above read on at least three parameters that are also claimed within claim 9, where “intensity” is equated to “amplitude”. Additionally, Zhu teaches “amplitude”, “pulse width”, “rate” (i.e., frequency) (see parameter field 962), which is the same three underlined above.
Regarding claims 10-11, the system and methods of Fang as combined with Zhu teach a system capable of allowing a user to provide any modulation function (see section 964 in Figure 9 of Zhu), or even to draw a custom modulation function (see Drawing Panel in Figure 11 of Zhu), and to provide any modulation frequency (see “Mod Frequency” within section 966 of Figure 9 of Zhu). As such, the system can allow a user to set the same or different modulation frequencies for any of the selected parameters in section 962 (i.e., amplitude, pulse width, rate or field/channel). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the same or different modulation frequencies for any of these parameters in Zhu (i.e., amplitude, pulse width, rate or field/channel) depending on the stimulation pulse sequence that results in effective treatment for the patient, based on the patient’s needs.
Regarding claim 13, the system and methods of Fang as combined with Zhu teach a system capable of allowing a user to provide any modulation function (see section 964 in Figure 9 of Zhu), or even to draw a custom modulation function (see Drawing Panel in Figure 11 of Zhu), and to provide any modulation frequency (see “Mod Frequency” within section 966 of Figure 9 of Zhu).
Regarding claim 17, it is noted that Fang teaches that a practitioner selected and sets parameters and a phase shift (see box 573). However, there is not discussion of the user interface, other than that “the system 100 can include one or more processors, memories and/or input/output devices” (see paragraph 20 of Fang). Zhu teaches a graphical user interface as illustrated in at least Figures 9-13. It is additionally noted that the drawing panel for a custom modulation function can allow for any desired phase offset to be applied, even if the preset options do not allow for such an offset.
Regarding claim 19, the system and methods of Fang as combined with Zhu teach a system capable of allowing a user to provide any modulation function (see section 964 in Figure 9 of Zhu), or even to draw a custom modulation function (see Drawing Panel in Figure 11 of Zhu), and to provide any modulation frequency (see “Mod Frequency” within section 966 of Figure 9 of Zhu).
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Ternes et al. (US Patent Pub. No. 2015/0258341).
Fang is described above with regard to claims 1 and 16. However, Fang fails to teach a warning provided on a display when/if the parameters selected in boxes 571 and/or 572 present an unsafe dose.
Ternes teaches “an implantable medical device (IMD) system that communications information to a user regarding the influence of surrounding biological environment on IMD functionality. … Providing information on the biological environment can assist the user in determining therapy parameters for an individual patient with an IMD” (see Abstract). A “controller 302 communicates the potential for nerve damage to the user by a visual stimulus, an audio tone/message, a vibration alert or the like or combinations thereof” (see paragraph 82). “The controller 302 creates a safety caution zone of parameter values that have a potential for nerve damage. The controller 302 may display an alert on the display 306, if the user selects the values of parameters that are in the safety caution zone” (see paragraph 83).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide warnings and/or alerts to a user when unsafe parameter selection(s) are made, as taught by Ternes, within the system and methods of Fang, in order to improve safety for the patient, as the location and biological environment in which the IMD is located can effect the ability of the device to deliver the desired therapy (see paragraph 3 of Ternes).
Allowable Subject Matter
Claims 7 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Also pending that the rejections under 35 USC 112(b) are overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES KISH/ Primary Examiner, Art Unit 3792
Prosecution Insights