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 .
Response to Amendment
The amendment filed February 3, 2026 has been entered. Claim 19 has been amended. Claim 1 was previously canceled. Currently, claims 2-38 are pending for examination.
Response to Arguments
Applicant's arguments filed February 3, 2026 have been fully considered but they are not persuasive.
Applicant argues against the Claim Interpretation that the limitation, “that is effective for treating pain of the patient without paresthesia” and “to treat pain without paresthesia” recited in method claim 1 is not a recitation of purpose or intended use. Applicant argues these limitations are statements of intentional purpose for which the methods must be performed, with support provided throughout the originally filed specification. After further evaluation, these limitations 1) do not positively recite the prevention of paresthesia while treating pain, and 2) do not result in a “manipulative difference” between the claimed invention and the prior art. In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). See MPEP 2111.02. Here, claim 1’s positively recited steps require receiving one or more operating parameters, generating a plurality of electrical pulses, and delivering the plurality of electrical pulses. Claim 1 does not require a positively recited step of preventing paresthesia, and only requires stimulation to dorsal fibers nerve tissue associated with a vertebral segment of the spinal cord at the thoracic or lumbar vertebral segment to comprise a plurality of electrical pulses that exhibit a pulse rate between 500 Hz and 10,000 Hz in the method for treating pain of the patient. As indicated by the 35 U.S.C. 103 rejection, Kim et al. (US 2006/0052826) discloses such plurality of electrical pulses, delivered at a pulse rate between 10 Hz to about 1000 Hz ([0091]) to the spinal dorsal root ganglion, thoracic ganglion, or lumbar ganglion ([0175]) in the same manner as required by the claimed invention, also for treating pain ([0079]). With the prior art’s manipulative steps being the same as claim 1, one in the art would reason the prior art would, under normal and usual operation, inherently also be effective for treating pain of the patient without paresthesia. See MPEP 2112.02.
Similarly the arguments toward claims 18 and 23 are unpersuasive as the claimed limitations 1) do not positively recite the prevention of paresthesia while treating pain, and 2) do not result in a “manipulative difference” between the claimed invention and the prior art. The invention as claimed is not different from the normal and usual operation of the prior art and would inherently provide treatment of pain without paresthesia.
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.
US Patent No. 11,633,598
Claims 2-13, 18-21, 23-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 14-15 of U.S. Patent No. 11,633,598 in view of Thimineur et al. (US 2006/0047325).
Claim 2 is directed to a method for treating pain of a patient, generating, by an implantable pulse generator, a stimulation that is effective for threatening pain of the patient without paresthesia according to one or more operating parameters, wherein the stimulation comprises a plurality of electrical pulses that exhibit a pulse rate between 500 Hz and 10,000 Hz; and delivering, by the IPG, the plurality of electrical pulses to at least one electrode of an implantable stimulation lead to stimulate nerve tissue associated with a vertebral segment of a spinal cord of the patient to treat pain without paresthesia, wherein the vertebral segment corresponds to a thoracic vertebral segment or a lumbar vertebral segment of the patient, and wherein the nerve tissue comprises dorsal fibers of the spinal cord associated with the thoracic vertebral segment or the lumbar vertebral segment. These limitations are disclosed by the patented claim 1. However patented claim 1 does not disclose receiving, by the IPG, the one or more operating parameters. Thimineur et al. teaches it is known in the art for an IPG 12 to comprise circuitry (“wireless receiver”) to receive one or more operating parameters (“control signals and power”) from a programmer 26 ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented claim 1 to incorporate the teachings of Thimineur et al. such as receiving, by the IPG, one or more operating parameters defining the stimulation, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Claim 18 is directed to a method for treating a patient, comprising an implantable pulse generator (IPG) of an implantable medical device (IMD) to deliver a paresthesia-free therapy signal to a spinal cord of the patient via at least one implantable stimulation lead, wherein the therapy signal has a plurality of pulses having an amplitude that is therapeutic to treat pain of the patient but does not generate paresthesia in the patient, and wherein the plurality of pulses exhibit a frequency in a frequency range from 500 Hz to 10,000 Hz. These limitations are disclosed by patented claim 1, and furthermore, it would have been obvious to one of ordinary skill in the art that the burst stimulation would comprise an amplitude (also broadly recited) that is therapeutic to treat pain of the patient but does not generate paresthesia in the patient given the same objective recited in the patented claim. However patented claim 1 does not disclose establishing, by a processor of a programming device, a wireless link with the IMD; and programming, by the processor, the IPG. Kim et al. does not expressly disclose establishing, by a processor of a programming device, a wireless link with the IMD; and programming, by the processor, the IPG. Thimineur et al. teaches it is known in the art for establishing, by a processor 26 of a programming device (“the external controller 26 can be for example, a handheld programmer”), a wireless link with an IMD 12 (“wireless transmitter 22 transmits the control signals and power to the wireless receiver of stimulation source 12”); and programming, by the processor 26, the IPG (“the external controller 26 can be for example, a handheld programmer, to provide a means for programming the IPG” [0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented claim 1 to incorporate the teachings of Thimineur et al. such as establishing, by a processor of a programming device, a wireless link with the IMD; and programming, by the processor, the IPG, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Claim 23 is directed to a method for treating pain of a patient, generating, by an implantable pulse generator, a stimulation that is effective for threatening pain of the patient without paresthesia according to one or more operating parameters, wherein the stimulation comprises a plurality of electrical pulses that exhibit a pulse rate between 100 Hz and 10,000 Hz; and delivering, by the IPG, the plurality of electrical pulses to at least one electrode of an implantable stimulation lead to stimulate nerve tissue associated with a vertebral segment of a spinal cord of the patient to treat pain without paresthesia, wherein the vertebral segment corresponds to a thoracic vertebral segment or a lumbar vertebral segment of the patient, and wherein the nerve tissue comprises dorsal fibers of the spinal cord associated with the thoracic vertebral segment or the lumbar vertebral segment. These limitations are disclosed by the patented claim 1, for the pulse rate range of 500 Hz to 10,000 Hz. However patented claim 1 does not disclose receiving, by the IPG, the one or more operating parameters. Thimineur et al. teaches it is known in the art for an IPG 12 to comprise circuitry (“wireless receiver”) to receive one or more operating parameters (“control signals and power”) from a programmer 26 ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented claim 1 to incorporate the teachings of Thimineur et al. such as receiving, by the IPG, one or more operating parameters defining the stimulation, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Claims 3 and 24 are rejected by patented claim 2.
Claims 4, 20 and 25 are rejected by patented claim 1.
Claims 5 and 26 are rejected by patented claim 3.
Claims 6 and 27 are rejected by patented claim 4.
Claims 7, 21 and 28 are directed to requiring the plurality of electrical pulses includes multiple bursts of electrical pulses (claims 4 and 25), and a period of quiescence follows each of the bursts of electrical pulses. While the patented claim does not expressly use the term “period of quiescence”, this limitations is broadly recited such that any stimulation off time would meet this requirement, including but not limited by a time interval separating two electrical pulses such as that recited by patented claims 7, 10, or 11.
Claims 8 and 29 are rejected by patented claim 5.
Claims 9 and 30 are rejected by patented claim 6.
Claim 10 and 31 are rejected by patented claim 7.
Claims 11 and 32 are rejected by patented claim 8.
Claims 12 and 33 are rejected by patented claim 14.
Claims 13 and 34 are rejected by patented claim 15.
Claim 19 is rejected by patented claim 1.
Claims 14-15 and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,633,598 in view of Thimineur et al. (US 2006/0047325) and Meadows et al. (US 6,381,496).
Claims 14-15 and 35-36 are directed to the one or more operating parameters comprise different parameter settings associated with different times or days. Patented claim 1 does not disclose these limitations. Meadows et al. teaches it is known in the art for operational parameters of a spinal cord stimulation system (col. 1, lines 9-19) to change from one set to another set at certain time of the week or month to account for different conditions that may arise (col. 3, lines 16-35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify patented claim 1 to modify the operating parameters to comprise different parameter settings associated with different days as taught by Meadows et al. in order to account for changing needs of the patient and as it is a known stimulation parameter for setting to stimulate the nerve tissue associated with the spinal cord, the results of such a modification being reasonably predictable.
Claims 16, 22 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,633,598 in view of Thimineur et al. (US 2006/0047325) and Bradley et al. (US 2005/0209655).
Claims 16, 22 and 37 are directed to delivering trial electrical pulses to the nerve tissue of the patient; configuring the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses; and providing the one or more operating parameters to the IPG. Patented claim 1 does not disclose these limitations. Bradley et al. teaches it is known in the art a spinal cord stimulation system ([0003]) to deliver trial electrical pulses to the nerve tissue of the patient (“trial stimulation parameter set”); configuring the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses (“patient provides feedback as to the effectiveness of the stimulation that is applied using the trial stimulation parameter set”); and providing the one or more operating parameters to an IPG 12 (fig. 2; “The testing and ranking of the trial stimulation parameter sets provides a coarse approximation of the stimulation which may be most effective” [0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify patented claim 1 to deliver trial electrical pulses to the nerve tissue of the patient; configure the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses; and provide the one or more operating parameters to the IPG as taught by Bradley et al. in order to judge and rank the effectiveness of different stimulation sets to a specific patient during a trial period by assessing their feedback, the results of such a modification being reasonably predictable.
Claims 17 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,633,598 in view of Thimineur et al. (US 2006/0047325) and Kim et al. (US 2006/0052826).
Claims 17 and 38 are directed to the at least one electrode comprises a plurality of electrodes. Patented claim 1 does not disclose this limitation. Kim et al. teaches it is known in the art for spinal cord stimulation device to comprise an implantable stimulation lead 110 with at least one electrode 115, wherein the at least one electrode comprises a plurality of electrodes (fig. 14a-b). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify patented claim 1 to use a lead with a plurality of electrodes to stimulate nerve tissue associated with a vertebral segment of a spinal cord as taught by Kim et al. as it is a known structure for use in similar devices, the results of such a modification would have been reasonably predictable.
US Patent No. 8,934,981
Claims 2-4, 7, 18-21, 23-25, 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 8-9, 17 of U.S. Patent No. 8,934,981 in view of Thimineur et al. (US 2006/0047325).
Claim 2 is directed to a method for treating pain of a patient, generating, by an implantable pulse generator, a stimulation that is effective for threatening pain of the patient without paresthesia according to one or more operating parameters, wherein the stimulation comprises a plurality of electrical pulses that exhibit a pulse rate between 500 Hz and 10,000 Hz; and delivering, by the IPG, the plurality of electrical pulses to at least one electrode of an implantable stimulation lead to stimulate nerve tissue associated with a vertebral segment of a spinal cord of the patient to treat pain without paresthesia, wherein the vertebral segment corresponds to a thoracic vertebral segment or a lumbar vertebral segment of the patient, and wherein the nerve tissue comprises dorsal fibers of the spinal cord associated with the thoracic vertebral segment or the lumbar vertebral segment. These limitations are disclosed by the patented claims 1, 8 and 17 (i.e. claim 2 “pulse rate between 500 Hz and 10,000 Hz” = patented claim 1 “pulse separation within a range of 0.1 milliseconds to 1.0 milliseconds”; claim 2 “thoracic vertebral segment or a lumbar vertebral segment” = patented claim 1 “lower back or legs of the patient”). However patented claims 1, 8 and 17 do not disclose receiving, by the IPG, the one or more operating parameters. Thimineur et al. teaches it is known in the art for an IPG 12 to comprise circuitry (“wireless receiver”) to receive one or more operating parameters (“control signals and power”) from a programmer 26 ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented claims 1, 8 and 17 to incorporate the teachings of Thimineur et al. such as receiving, by the IPG, one or more operating parameters defining the stimulation, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Claim 18 is directed to a method for treating a patient, comprising an implantable pulse generator (IPG) of an implantable medical device (IMD) to deliver a paresthesia-free therapy signal to a spinal cord of the patient via at least one implantable stimulation lead, wherein the therapy signal has a plurality of pulses having an amplitude that is therapeutic to treat pain of the patient but does not generate paresthesia in the patient, and wherein the plurality of pulses exhibit a frequency in a frequency range from 500 Hz to 10,000 Hz. These limitations are disclosed by patented claims 1 and 9 (i.e. claim 2 “pulse rate between 500 Hz and 10,000 Hz” = patented claim 1 “pulse separation within a range of 0.1 milliseconds to 1.0 milliseconds”), and furthermore, it would have been obvious to one of ordinary skill in the art that the burst stimulation would comprise an amplitude (also broadly recited) that is therapeutic to treat pain of the patient but does not generate paresthesia in the patient given the same objective recited in the patented claim. However patented claims 1 and 9 do not disclose establishing, by a processor of a programming device, a wireless link with the IMD; and programming, by the processor, the IPG. Kim et al. does not expressly disclose establishing, by a processor of a programming device, a wireless link with the IMD; and programming, by the processor, the IPG. Thimineur et al. teaches it is known in the art for establishing, by a processor 26 of a programming device (“the external controller 26 can be for example, a handheld programmer”), a wireless link with an IMD 12 (“wireless transmitter 22 transmits the control signals and power to the wireless receiver of stimulation source 12”); and programming, by the processor 26, the IPG (“the external controller 26 can be for example, a handheld programmer, to provide a means for programming the IPG” [0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented claims 1 and 9 to incorporate the teachings of Thimineur et al. such as establishing, by a processor of a programming device, a wireless link with the IMD; and programming, by the processor, the IPG, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Claim 23 is directed to a method for treating pain of a patient, generating, by an implantable pulse generator, a stimulation that is effective for threatening pain of the patient without paresthesia according to one or more operating parameters, wherein the stimulation comprises a plurality of electrical pulses that exhibit a pulse rate between 100 Hz and 10,000 Hz; and delivering, by the IPG, the plurality of electrical pulses to at least one electrode of an implantable stimulation lead to stimulate nerve tissue associated with a vertebral segment of a spinal cord of the patient to treat pain without paresthesia, wherein the vertebral segment corresponds to a thoracic vertebral segment or a lumbar vertebral segment of the patient, and wherein the nerve tissue comprises dorsal fibers of the spinal cord associated with the thoracic vertebral segment or the lumbar vertebral segment. These limitations are disclosed by the patented claims 1, 8 and 17, for the pulse rate range of 500 Hz to 10,000 Hz (i.e. claim 2 “pulse rate between 500 Hz and 10,000 Hz” = patented claim 1 “pulse separation within a range of 0.1 milliseconds to 1.0 milliseconds”; claim 2 “thoracic vertebral segment or a lumbar vertebral segment” = patented claim 1 “lower back or legs of the patient”). However patented claims 1, 8 and 17 do not disclose receiving, by the IPG, the one or more operating parameters. Thimineur et al. teaches it is known in the art for an IPG 12 to comprise circuitry (“wireless receiver”) to receive one or more operating parameters (“control signals and power”) from a programmer 26 ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented claims 1, 8 and 17 to incorporate the teachings of Thimineur et al. such as receiving, by the IPG, one or more operating parameters defining the stimulation, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Claims 3 and 24 are rejected by patented claim 6.
Claims 4, 20 and 25 are rejected by patented claim 1.
Claims 7, 21 and 28 are rejected by patented claims 4 and 9.
Claim 19 is rejected by patented claim 1 (i.e. claim 19 “thoracic vertebral segment or a lumbar vertebral segment” = patented claim 1 “lower back or legs of the patient” (also see patented claim 8)) and patented claim 17.
Claims 16, 22 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9 and 17 of U.S. Patent No. 11,633,598 in view of Thimineur et al. (US 2006/0047325) and Bradley et al. (US 2005/0209655).
Claims 16, 22 and 37 are directed to delivering trial electrical pulses to the nerve tissue of the patient; configuring the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses; and providing the one or more operating parameters to the IPG. Patented claims 1, 8, 9 and 17 do not disclose these limitations. Bradley et al. teaches it is known in the art a spinal cord stimulation system ([0003]) to deliver trial electrical pulses to the nerve tissue of the patient (“trial stimulation parameter set”); configuring the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses (“patient provides feedback as to the effectiveness of the stimulation that is applied using the trial stimulation parameter set”); and providing the one or more operating parameters to an IPG 12 (fig. 2; “The testing and ranking of the trial stimulation parameter sets provides a coarse approximation of the stimulation which may be most effective” [0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify patented claims 1, 8, 9 and 17 to deliver trial electrical pulses to the nerve tissue of the patient; configure the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses; and provide the one or more operating parameters to the IPG as taught by Bradley et al. in order to judge and rank the effectiveness of different stimulation sets to a specific patient during a trial period by assessing their feedback, the results of such a modification being reasonably predictable.
Claim Interpretation
Claims 2, 18-20, 23 all recite the limitation “treating pain of the patient without paresthesia” in some general form. This limitation is regarded as reciting purpose or intended use that does not result in a manipulative difference between the claimed invention and the prior art and therefore does not serve to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 2, 4, 7, 17-21, 23, 25, 28, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2006/0052826) in view of Thimineur et al. (US 2006/0047325).
Regarding claim 2, Kim et al. discloses a method for treating pain of a patient ([0079]), the method comprising: generating, by an implantable pulse generator (IPG) 100 ([0088]), a stimulation according to one or more operating parameters, wherein the stimulation comprises a plurality of electrical pulses that exhibit a pulse rate between 500 Hz and 10,000 Hz (“10 Hz to about 1000 Hz” [0091]); and delivering, by the IPG, the plurality of electrical pulses to at least one electrode 115 (fig. 4a) of an implantable stimulation lead 110 to stimulate nerve tissue associated with a vertebral segment of a spinal cord of the patient, wherein the vertebral segment corresponds to a thoracic vertebral segment or a lumbar vertebral segment of the patient, and wherein the nerve tissue comprises dorsal fibers of the spinal cord associated with the thoracic vertebral segment or the lumbar vertebral segment (“stimulating a spinal dorsal root ganglion…a thoracic ganglion, or a lumbar ganglion” [0175]).
Kim et al. does not expressly disclose the IPG receiving the one or more operating parameters defining the stimulation. Thimineur et al. teaches it is known in the art for an IPG 12 to comprise circuitry (“wireless receiver”) to receive one or more operating parameters (“control signals and power”) from a programmer 26 ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to incorporate the teachings of Thimineur et al. such as receiving, by the IPG, one or more operating parameters defining the stimulation, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Kim et al. does not expressly disclose the stimulation is effective for treating pain of the patient without paresthesia. As stated above (see claim interpretation), When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that given Kim et al. discloses delivering the claimed stimulation parameters to the same claimed nerve tissue, the same resultant treatment of pain of the patient without paresthesia would occur. No additional parameters are provided to distinguish the claimed invention from the prior art.
Regarding claim 4, Kim et al. discloses wherein the plurality of electrical pulses includes multiple bursts of electrical pulses (“an oscillating electrical signal may be applied continuously or intermittently” [0089]).
Regarding claim 7, Kim et al. discloses wherein a period of quiescence follows each of the bursts of electrical pulses (“A signal of "stimulation on"… “an oscillating electrical signal may be applied continuously or intermittently” [0089]; (1) if a “stimulation on” is provided, then a “stimulation off” is regarded as the period of quiescence, (2) intermittently delivered electrical signal indicates a period of quiescence).
Regarding claim 17, Kim et al. discloses wherein the at least one electrode 115 comprises a plurality of electrodes (fig. 14a-b).
Regarding claim 18, Kim et al. discloses a method for treating a patient, comprising: programming ([0080]), an implantable pulse generator (IPG) 105A of an implantable medical device (IMD) (fig. 27) to deliver a therapy signal to a spinal cord of the patient via at least one implantable stimulation lead 110, wherein the therapy signal has a plurality of pulses having an amplitude (“a voltage between about 0.5 V to about 20 V” [0091]) and wherein the plurality of pulses exhibit a frequency in a frequency range from 500 Hz to 10,000 Hz (“10 Hz to about 1000 Hz” [0091]).
Kim et al. does not expressly disclose establishing, by a processor of a programming device, a wireless link with the IMD; and programming, by the processor, the IPG. Thimineur et al. teaches it is known in the art for establishing, by a processor 26 of a programming device (“the external controller 26 can be for example, a handheld programmer”), a wireless link with an IMD 12 (“wireless transmitter 22 transmits the control signals and power to the wireless receiver of stimulation source 12”); and programming, by the processor 26, the IPG (“the external controller 26 can be for example, a handheld programmer, to provide a means for programming the IPG” [0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to incorporate the teachings of Thimineur et al. such as establishing, by a processor of a programming device, a wireless link with the IMD; and programming, by the processor, the IPG, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Kim et al. does not expressly disclose the therapy signal is a paresthesia-free therapy signal and the amplitude is therapeutic to treat paint of the patient but does not generate paresthesia in the patient. As stated above (see claim interpretation), When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that given Kim et al. discloses delivering the claimed stimulation parameters to the same claimed nerve tissue, the same resultant treatment of pain of the patient without paresthesia would occur. No additional parameters are provided to distinguish the claimed invention from the prior art.
Regarding claim 19, Kim et al. in view of Thimineur et al. disclose receiving, by the IMD, one or more operating parameters (“control signals and power” [0060]) based on the programming, the one or more operating parameters defining the stimulation ([0060]); and delivering, by the IPG, the therapy signal to nerve tissue associated with a vertebral segment of a spinal cord of the patient, wherein the vertebral segment corresponds to a thoracic vertebral segment or a lumbar vertebral segment of the patient, and wherein the nerve tissue comprises dorsal fibers associated with the thoracic vertebral segment or the lumbar vertebral segment (“stimulating a spinal dorsal root ganglion…a thoracic ganglion, or a lumbar ganglion” [0175]).
Regarding claim 20, Kim et al. discloses wherein the therapy signal includes multiple bursts of electrical pulses (“an oscillating electrical signal may be applied continuously or intermittently” [0089]).
Regarding claim 21, Kim et al. discloses wherein a period of quiescence follows each of the multiple bursts of electrical pulses (“A signal of "stimulation on"… “an oscillating electrical signal may be applied continuously or intermittently” [0089]; (1) if a “stimulation on” is provided, then a “stimulation off” is regarded as the period of quiescence, (2) intermittently delivered electrical signal indicates a period of quiescence).
Regarding claim 23, Kim et al. discloses a method for treating pain of a patient, the method comprising: generating, by an implantable pulse generator (IPG) 100 ([0088]), a stimulation according to one or more operating parameters, wherein the stimulation comprises a plurality of electrical pulses that exhibit a pulse rate between 100 Hz and 10,000 Hz (“10 Hz to about 1000 Hz” [0091]); and delivering, by the IPG, the plurality of electrical pulses to at least one electrode 115 (fig. 4a) of an implantable stimulation lead 110 to stimulate nerve tissue associated with a vertebral segment of a spinal cord of the patient, wherein the vertebral segment corresponds to a thoracic vertebral segment or a lumbar vertebral segment of the patient, and wherein the nerve tissue comprises dorsal fibers of the spinal cord associated with the thoracic vertebral segment or the lumbar vertebral segment (“stimulating a spinal dorsal root ganglion…a thoracic ganglion, or a lumbar ganglion” [0175]).
Kim et al. does not expressly disclose the IPG receiving the one or more operating parameters defining the stimulation. Thimineur et al. teaches it is known in the art for an IPG 12 to comprise circuitry (“wireless receiver”) to receive one or more operating parameters (“control signals and power”) from a programmer 26 ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to incorporate the teachings of Thimineur et al. such as receiving, by the IPG, one or more operating parameters defining the stimulation, in order to allow for a doctor, patient or another user of the IPG to communicate and control operation of the IPG ([0060]).
Kim et al. does not expressly disclose the stimulation is effective for treating pain of the patient without paresthesia. As stated above (see claim interpretation), When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that given Kim et al. discloses delivering the claimed stimulation parameters to the same claimed nerve tissue, the same resultant treatment of pain of the patient without paresthesia would occur. No additional parameters are provided to distinguish the claimed invention from the prior art.
Regarding claim 25, Kim et al. discloses wherein the plurality of electrical pulses includes multiple bursts of electrical pulses (“an oscillating electrical signal may be applied continuously or intermittently” [0089]).
Regarding claim 28, Kim et al. discloses wherein a period of quiescence follows each of the bursts of electrical pulses (“A signal of "stimulation on"… “an oscillating electrical signal may be applied continuously or intermittently” [0089]; (1) if a “stimulation on” is provided, then a “stimulation off” is regarded as the period of quiescence, (2) intermittently delivered electrical signal indicates a period of quiescence).
Regarding claim 38, Kim et al. discloses wherein the at least one electrode 115 comprises a plurality of electrodes (fig. 14a-b).
Claim(s) 3, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2006/0052826) in view of Thimineur et al. (US 2006/0047325) and further in view of Whitehurst et al. (US 2005/0119713).
Regarding claims 3, 24, Kim et al. does not expressly disclose wherein the plurality of electrical pulses include a series of electrical pulses with increasing amplitude. Whitehurst et al. teaches a neurostimulation device for stimulating the lumbar vertebral segment ([0072]) where it is known in the art for the amplitude of a series of stimulation pulses to be increased in response to increased neural activity ([0073], [0082]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. such that the plurality of electrical pulses increase in amplitude as taught by Whitehurst et al. in order to enable stimulation parameters to adjust in response to increased neural activity ([0082]).
Claim(s) 5-6, 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2006/0052826) in view of Thimineur et al. (US 2006/0047325) and further in view of De Ridder (US 2006/0095088).
Regarding claims 5-6 and 26-27, Kim et al. does not expressly disclose wherein the multiple bursts of electrical pulses have an inter-burst frequency in a range of about 40 Hz to 50 Hz. De Ridder teaches a device for stimulating nerve tissue associated with the spinal cord where multiple bursts (“spikes”) of electrical pulses are delivered, wherein the multiple bursts of electrical pulses have an inter-burst frequency in the range of about 40 Hz to 50 Hz (“The interval between spikes (e.g., inter-spike interval) can be about 0.5 milliseconds to about 100 milliseconds” [0015]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to try delivering the electrical pulses in multiple bursts where there is an inter-burst frequency of about 40 Hz to 50 Hz as taught by De Ridder as it is a known stimulation parameter for setting to stimulate the nerve tissue associated with the spinal cord, the results of such a modification being reasonably predictable.
Claim(s) 8-9, 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2006/0052826) in view of Thimineur et al. (US 2006/0047325) and further in view of King (US 2005/0149148).
Regarding claims 8-9, 29-30, Kim et al. does not expressly disclose wherein the plurality of electrical pulses is preceded by a pre-conditioning hyper-polarizing electrical pulse. King teaches it is known in the art in spinal cord stimulation to deliver a pre-conditioning ([0041]) hyperpolarizing ([0043]) blocking stimulation pulse (fig. 2) in order to effectively prevent an undesirable side effect of spinal cord stimulation in other areas of the patient’s body ([0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to incorporate a pre-conditioning hyperpolarizing electrical pulse as taught by King in order to help prevent an undesirable side effect of spinal cord stimulation in other areas of the patient’s body when the intended stimulation is delivered ([0041]).
Claim(s) 10-13, 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2006/0052826) in view of Thimineur et al. (US 2006/0047325) and further in view of King et al. (US 2006/0079937).
Regarding claims 10 and 31, Kim et al. does not expressly disclose wherein the plurality of electrical pulses comprises a group of at least two electrical pulses separated by a time interval of between about 0.1 and about 10 milliseconds. King et al. teaches a similar electrical pulse generator for stimulating nerve tissue associated with the spinal cord (fig. 1) where pulses do not overlap in time and have a displaced time period of 500-2000 microseconds ([0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to try separating at least two electrical pulses by a time interval of between about 0.1 and about 10 milliseconds as taught by King et al. as it is a known stimulation parameter for setting to stimulate the nerve tissue associated with the spinal cord, the results of such a modification being reasonably predictable.
Regarding claims 11 and 32, Kim et al. in view of King et al. disclose wherein the plurality of electrical pulses comprises two or more such groups (“P1 and P2” and “P3 and P4” [0049-0050], fig. 8-9).
Regarding claims 12 and 33, Kim et al. does not expressly disclose the plurality of electrical pulses exhibit a fixed inter-pulse interval. King et al. teaches a similar electrical pulse generator for stimulating nerve tissue associated with the spinal cord (fig. 1) where pulses do not overlap in time and have a fixed inter-pulse interval of 500-2000 microseconds ([0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to try using a fixed inter-pulse interval as taught by King et al. as it is a known stimulation parameter for setting to stimulate the nerve tissue associated with the spinal cord, the results of such a modification being reasonably predictable.
Regarding claim 13 and 34, Kim et al. does not expressly disclose the plurality of electrical pulses exhibit variations in inter-pulse intervals. King et al. teaches a similar electrical pulse generator for stimulating nerve tissue associated with the spinal cord (fig. 1) where pulses do not overlap in time and have variations in inter-pulse intervals (“weighted average time… The rise time and fall time of a pulse can affect the weighted average time of the pulse” [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to try using variations in inter-pulse intervals as taught by King et al. as it is a known stimulation parameter for setting to stimulate the nerve tissue associated with the spinal cord, the results of such a modification being reasonably predictable.
Claim(s) 14-15, 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2006/0052826) in view of Thimineur et al. (US 2006/0047325) and further in view of Meadows et al. (US 6,381,496).
Regarding claims 14-15, 35-36, Kim et al. does not expressly disclose wherein the one or more operating parameters comprise different parameter settings associated with different days. Meadows et al. teaches it is known in the art for operational parameters of a spinal cord stimulation system (col. 1, lines 9-19) to change from one set to another set at certain time of the week or month to account for different conditions that may arise (col. 3, lines 16-35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to modify the operating parameters to comprise different parameter settings associated with different days as taught by Meadows et al. in order to account for changing needs of the patient and as it is a known stimulation parameter for setting to stimulate the nerve tissue associated with the spinal cord, the results of such a modification being reasonably predictable.
Claim(s) 16, 22, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2006/0052826) in view of Thimineur et al. (US 2006/0047325) and further in view of Bradley et al. (US 2005/0209655).
Regarding claims 16, 22, and 37, Kim et al. does not expressly disclose delivering trial electrical pulses to the nerve tissue of the patient; configuring the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses; and providing the one or more operating parameters to the IPG. Bradley et al. teaches it is known in the art a spinal cord stimulation system ([0003]) to deliver trial electrical pulses to the nerve tissue of the patient (“trial stimulation parameter set”); configuring the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses (“patient provides feedback as to the effectiveness of the stimulation that is applied using the trial stimulation parameter set”); and providing the one or more operating parameters to an IPG 12 (fig. 2; “The testing and ranking of the trial stimulation parameter sets provides a coarse approximation of the stimulation which may be most effective” [0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. to deliver trial electrical pulses to the nerve tissue of the patient; configure the one or more operating parameters based on feedback from the patient subsequent to delivering the trial electrical pulses; and provide the one or more operating parameters to the IPG as taught by Bradley et al. in order to judge and rank the effectiveness of different stimulation sets to a specific patient during a trial period by assessing their feedback, the results of such a modification being reasonably predictable.
Conclusion
THIS ACTION IS MADE FINAL. 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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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