DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
The Specification objections are withdrawn in light of the amendments received. The 35 USC §112 rejections are withdrawn in favor of the below 35 USC § 112 rejections below. The Double Patenting rejections are withdrawn in light of the terminal disclaimer received and approved.
Applicant’s arguments, see Applicant’s Response, filed 8/6/2026, with respect to the rejections of claims 1-8 and 11-20 under Lee/Sluijter have been fully considered and are persuasive, in light of the amendments made. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of WO 2005/002663 to Kronberg.
Claim 1 has been amended to include limitations from previously presented claim 3. Previously presented claim 3 recited, in its entirety: “The method of claim 1, wherein the plurality of modulating signals has a plurality of respective shapes, and selecting the waveform comprises selecting a shape from the plurality of respective shapes.”
Applicant argues that the primary reference (Lee et al. US 8,036,754) does not teach modulated signals (see page 9) and that the secondary reference (Sluijter et al. US 6,246,912. However this is addressed through the 103 rejections. Lee is clearly disclosing selecting waveforms which each have a plurality of parameters (column 2, lines 48-52 and column 3, lines 36 through column 4 line 10). These lines read; “In one method, the pulse shape is modified by selecting one of a plurality of different pulse shape types (e.g. a square pulse, an exponential pulse, a logarithmic pulse, a ramped pulse and a trapezoidal pulse, or a combination thereof”. This is clearly disclosing selecting a waveform shape. With respect to the modulated signal, this is disclosed in the secondary reference to Sluijter, which is an amplitude modulated signal (column 14, lines 44-47), amplitude modulation is known in the art. Note that claim 1, as previously presented recited the language “a parameter modulated by a modulating signal” and claim 3 recites that each modulated signal has a plurality of selected shapes. This can be broadly interpreted to be that the carrier signal has a shape which is then amplitude modulated. Therefore, the 103 rejection made specificizes that the shape of the signal is chosen in Lee, and the only missing component is that the amplitude is then modulated with is clearly taught in Sluijter.
However upon amendment (8/6/2026), each independent claim now recites “selecting a waveform from a plurality of waveforms using a programming device, the waveforms each having a plurality of parameters defining a pulse train, the plurality of parameters including a parameter modulated by a modulated signal selected from a plurality of modulating signals having a plurality of respective shapes.” First, the addition of the language using a programming device narrows the claim language. Secondly, the language as now amended is indefinite. In this language each waveform has a plurality of parameters for a pulse train and a parameter is modulated, which could be amplitude modulation. However, it is not clear how the plurality of parameters including a parameter modulated by a modulated signal can be selected from a plurality of shapes. This seems to indicate that waveforms parameters (amplitude, frequency, pulse width etc.) including the modulated parameter are selected based on shape which is not clear. Previously presented claim 3 was clear, however the method in which claim 1 has been amended is now unclear.
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 1-21 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.
Independent claims 1, 11 and 20 each recite “selecting a waveform from a plurality of waveforms using a programming device, the waveforms each having a plurality of parameters defining a pulse train, the plurality of parameters including a parameter modulated by a modulation signal selected from a plurality of modulating signals having a plurality of respective shapes” (claim 1, lines 3-6; claim 11, lines 4-7 and claim 20, lines 4-7). In this language each waveform has waveform parameters for a pulse train, these would include parameters such as amplitude, pulse width and pulse duration. One of the parameters is modulated by a modulation signal. This signal was previously interpreted to be a signal to initiate modulation. However, in this newly amended language there is a modulated parameter which is somehow modulated by a signal which is selected from a plurality of modulated signals which have respective shapes. For instance how are amplitude or pulse width modulated by a respective shape? This language is not understood and is therefore indefinite. It will be assumed, for the purpose of expedited prosecution, that a parameter is modulated to create a modulated signal with the modulated parameter creating a modulated signal and the shape of the final modulated waveform is based on the initial waveform chosen.
The remainder of the dependent claims are also rejected because they depend from independent claims 1, 11 or 20 which are rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-8 and 11-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. US 8,036,754 previously cited in view of Sluijter et al. US 6,246,912 previously cited and further in view of Kronberg WO 2005/002663.
Regarding claim 1: Lee discloses stimulation of neural tissue (“spinal cord tissue”, abstract) comprising:
selecting a waveform using a programming device 16/18/20 (figure 1, column 15, lines “Pulse Shape Adjustment Mode”, column 15, lines 27-67) from a plurality of waveforms each having a plurality of parameters defining a pulse train (column 2, lines 48-52; column 3, line 63 through column 4 line 10, figures 3-4),
delivering the energy using the device (column 9, lines 39-41);
programming the device, using the programming device to control delivery of energy to the neural tissue from a neuromodulator device 10 (IPG, column 4, lines 10-13; device 16/18/20 figure 1, column 15, lines “Pulse Shape Adjustment Mode”, column 15, lines 27-67 and column 2, lines 48-52; column 3, line 63 through column 4 line 10, figures 3-4) and
selecting the waveform shape from a plurality of shapes (figures 3-4, 14 and 18).
However, Lee appears to be disclosing a single waveform and not a modulated waveform. In this case, a modulated waveform is considered to include a modulation of a parameter in a waveform such as amplitude modulation of a waveform. Sluijter however teaches of a signal generator 305 (figure 11) connected to a modulator 304 (figure 11). In this configuration the signal generator outputs a signal, considered to be a waveform, which is then modulated, the example given is amplitude modulation (column 14, lines 44-47). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lee to include amplitude modulation, as taught by Sluijter, in order to treat pain syndrome (column 14, line 23 of Sluijter).
Lee/Sluijter therefore disclose the claimed invention however Lee/Sluijter does not specifically disclose selecting the waveform which includes selecting a shape of a modulated signal. Kronberg however teaches of a user begin able to choose an asymmetrical-modulated pulse-train, a square wave modulated signal or a quasi-sinusoidal signal (page 50, lines 29-35; “A third specific embodiment of the invention, shown in Figure 26, is designed to produce from the same compact device, and at the user's choice, either an asymmetrically-modulated pulse-train signal similar to that of Figure 4, suitable for tissue healing stimulation and pain relief; a square-wave-modulated signal of similar form, suitable for muscle stimulation; or a quasi-sinusoidal signal like that of the previous embodiment, suitable for interferential stimulation.”). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lee/Sluijter to include selecting the waveform which includes selecting a shape of a modulated signal, as taught by Kronberg, in order to treat various conditions such as pain, muscle stimulation and healing.
Regarding claims 2 and 4 and 12-15: Lee discloses displaying different wave shapes, which are waveforms, in figure 18, the user in figure 18 is selecting 113(2). Also see column 15, lines 1-67. The user interface includes buttons 106/108/110/112 and display 102 (figure 17), the waveforms are displayed as is shown in figure 18, the waveform 113(2) is being chosen/selected by the user interface. The user interface also allows for parameter adjustment (column 15, lines 1-3). Also see column 5, lines 34-40; column 15, lines 1-67).
Regarding claims 5 and 16: Lee discloses a square waveform 113(1); sinusoidal waveform 113(9) in figure 18; these are considered to be respective shapes.
Regarding claims 6 and 17: Lee discloses a plurality of waveforms (figure 18) as well as modulating by a stepped wave (column 3, lines 44-49).
Regarding claims 7 and 18-19: Lee discloses that the pulse parameters as well as the waveshape can be modified independent of each other (column 2, lines 59-63). Lee further discloses external device 16 (figure 17) which also includes display 102 (figure 17). Lee further discloses that any stimulation parameter can be adjusted (column 15, lines 8-12) via the user interface.
Regarding claim 8: Lee discloses providing a plurality of waveforms in figures 9-10, inherently each waveform has an amplitude, or in this case multiple amplitudes. However, Lee does not discuss pulse amplitude modulated by a modulating signal. Sluijter however teaches of a signal generator 305 (figure 11) connected to a modulator 304 (figure 11). In this configuration the signal generator outputs a signal, considered to be a waveform, which is then modulated, the example given is amplitude modulation (column 14, lines 44-47). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lee to include amplitude modulation, as taught by Sluijter, in order to treat pain syndrome (column 14, line 23 of Sluijter).
Regarding claims 11 and 20: Lee discloses a neural stimulation system (“spinal cord tissue” and “stimulation system”, abstract) which includes a stimulation device 14 (figure 1) with a programming device 16 (“RC”, figure 1) which includes non-transitory memory (column 3, lines 54-58, ) with instructions storing memory (column 11, lines 55-60), the programming device comprising:
selecting a waveform from a plurality of waveforms each having a plurality of parameters defining a pulse train (column 2, lines 48-52; column 3, line 63 through column 4 line 10),
delivering energy to the neural tissue from a neuromodulator device 10 (IPG, column 4, lines 10-13) and
controlling the delivery of the energy according to the selected waveform (column 9, lines 39-41).
However, Lee appears to be disclosing a single waveform and not a modulated waveform. In this case, a modulated waveform is considered to include a carrier wave which modulates an intended waveform. Sluijter however teaches of a signal generator 305 (figure 11) connected to a modulator 304 (figure 11). In this configuration the signal generator outputs a signal, considered to be a waveform, which is then modulated, the example given is amplitude modulation (column 14, lines 44-47). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lee to include amplitude modulation, as taught by Sluijter, in order to treat pain syndrome (column 14, line 23 of Sluijter).
Lee/Sluijter therefore disclose the claimed invention however Lee/Sluijter does not specifically disclose selecting the waveform which includes selecting a shape of a modulated signal. Kronberg however teaches of a user begin able to choose an asymmetrical-modulated pulse-train, a square wave modulated signal or a quasi-sinusoidal signal (page 50, lines 29-35; “A third specific embodiment of the invention, shown in Figure 26, is designed to produce from the same compact device, and at the user's choice, either an asymmetrically-modulated pulse-train signal similar to that of Figure 4, suitable for tissue healing stimulation and pain relief; a square-wave-modulated signal of similar form, suitable for muscle stimulation; or a quasi-sinusoidal signal like that of the previous embodiment, suitable for interferential stimulation.”). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lee/Sluijter to include selecting the waveform which includes selecting a shape of a modulated signal, as taught by Kronberg, in order to treat various conditions such as pain, muscle stimulation and healing.
Regarding claim 21: Lee discloses the neuromodulation device 14 (IPG, figure 12), which is an implantable pulse generator, and the programming device 16 (figure 17) which is configured for telemetry and programming the IPG (column 3, lines 50-62), the telemetry is bidirectional link considered to be an RC communication link (column 13, lines 20-65).
Claims 9-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. US 8,036,754 previously cited in view of Sluijter et al. US 6,246,912 previously cited and further in view of Kronberg WO 2005/002663 and further in view of Su et al. US 2012/0197338 previously cited.
Regarding claims 9-10: Lee/Sluijter/Kronberg discloses the claimed invention however Lee/Sluijter/Kronsberg does not disclose modulation of pulse duration and/or pulse rate. Su however teaches of a stimulation therapy system which modulates parameters including amplitude, pulse width and pulse duration (paragraph 0046). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Lee/Sluijter/Kronberg to include amplitude, pulse width and pulse duration modulation, as taught by Su in order to attain the desired therapeutic effect (Su, paragraph 0046).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paula J. Stice whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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, Benjamin Klein can be reached at 571-272-5213. 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.
PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
