CTNF 18/770,423 CTNF 86731 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Specification 07-29 AIA The disclosure is objected to because of the following informalities: paragraph 0001 should be updated to reflect the status of the copending applications (now allowed) . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-10 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 “selecting a waveform from a plurality of waveforms each having a plurality of parameters defining a pulse train”. In this methods claim it is unclear when and how this selecting step occurs. Under broadest reasonable interpretation this could be prior to programming during a research state or it could be performed by the device or at any point during use. This language is unclear and therefore indefinite. Claims 2-10 are also rejected in that they depend from a previously rejected claim. Claim Rejections - 35 USC § 103 07-20-fti 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. 07-21-fti Claim s 1-8 and 11-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. US 8,036,754 in view of Sluijter et al. US 6,246,912 . Regarding claim 1: Lee discloses stimulation of neural tissue (“spinal cord tissue”, abstract) 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). Regarding claims 2-4 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 claim 11: 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) . 07-21-fti Claim s 9-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. US 8,036,754 in view of Sluijter et al. US 6,246,912 and further in view of Su et al. US 2012/0197338 . Regarding claims 9-10: Lee/Sluijter discloses the claimed invention however Lee/Sluijter 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 to include amplitude, pulse width and pulse duration modulation, as taught by Su in order to attain the desired therapeutic effect (Su, paragraph 0046). Double Patenting 08-33 AIA 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. 08-34 Claims 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,507,328. Although the claims at issue are not identical, they are not patentably distinct from each other. 18/770,423 10,507,328 11. A system for modulating neural tissue using a neuromodulator device, comprising: a programming device configured to: select a waveform from a plurality of waveforms each having a plurality of parameters defining a pulse train , the plurality of parameters including a parameter modulated by a modulating signal selected from a plurality of modulating signals; and program the neuromodulator device to deliver neuromodulation energy to the neural tissue and to control the delivery of the neuromodulation energy according to the selected waveform. 12. The system of claim 11, wherein the programming device comprises a user interface configured to display the plurality of waveforms and to receive a selection of the waveform from the displayed plurality of waveforms . 1. A system including an external device, wherein the external device includes a user interface with a display , and wherein the external device is configured for: presenting, on the display of the external device, a plurality of waveforms available for selection by a user , wherein at least one of the plurality of waveforms comprises a modulated pulse train , wherein an attribute of at least a portion of the modulated pulse train is modulated by a modulating signal, thereby providing an attribute for each pulse of the at least the portion of the modulated pulse train that corresponds to an attribute of the modulating signal; receiving a user input through the user interface, the user input being indicative of a user selection of at least one of the plurality of waveforms presented on the display of the external device ; and generating a program for a neurostimulator to deliver neuromodulation to neural tissue in accordance with the selected at least one waveform , wherein the neuromodulation delivered to neural tissue includes the modulated pulse train delivered to the neural tissue. Conclusion 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, Carl H Layno can be reached at 571-272-4949. 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 Application/Control Number: 18/770,423 Page 2 Art Unit: 3796 Application/Control Number: 18/770,423 Page 3 Art Unit: 3796 Application/Control Number: 18/770,423 Page 4 Art Unit: 3796
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