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 Arguments
Applicant’s arguments with respect to the claims have been considered but are not persuasive as claim 12 discloses the tissue groups include two or more neural targets. Applicant argues that Li does not teach this limitation and does not explicitly disclose how the examiner’s analysis with regard to Block is deficient. Therefore, the rejection of claims 1 and 14 have been changed to a 103 rejection in light of Block.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US Publication 2015/0119958) in view of Block et al (US Publication 2020/0376272).
Referring to Claims 1 and 14, Li et al teaches a neuromodulation system/method for providing neuromodulation, comprising: an electrostimulator operably coupled to a lead system adapted to be located or near a stimulation site of a patient to provide neuromodulation energy thereto (e.g. Figure 1, Element 14 or 20); a controller circuit configured to: based at least in part on information about lead placement, identify distinct electrode-tissue contact groups each comprising one or more neural targets in association with one or more electrodes of the lead system (e.g. Paragraphs [0021], [0056]-[0057] discloses a controller that retrieves medical image relative to anatomical structure); determine a stimulation mode for at least one of the distinct electrode-tissue contact groups (e.g. Paragraph [0021] discloses generating a set of stimulation parameters based on the user input and the detected location of the neurostimulation lead(s) relative to the anatomical structure); generate a control signal to the electrostimulator to provide neuromodulation energy to the one or more neural targets of the at least one of the identified distinct electrode-tissue contact groups in accordance with the determined stimulation mode (e.g. Paragraph [0021] discloses generating a set of stimulation parameters based on the user input and the detected location of the neurostimulation lead(s) relative to the anatomical structure). However, Li et al does not explicitly disclose comprising two or more neural targets.
Block et al teaches that it is known to use the controller selecting neural structures individually on a patient and across different neural structures (e.g. dorsal roots and dorsal root ganglia) to as set forth in Figure 21 and Paragraphs [0118] and [0135] to provide improved therapy programming precision by optimizing the target neuromodulation field based on the patient’s anatomy, electrode position, and various neural structures thereby resulting in better therapeutic outcome. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Li et al, with the identified distinct electrode-tissue contact groups include a first electrode-tissue contact group comprising two or more neural targets, wherein the controller circuit is configured to determine respective stimulation modes for stimulating the two or more neural targets of the first electrode-tissue contact group; select a neural target from the two or more neural targets based on patient responses to test neuromodulation energy individually and independently delivered to the two or more neural targets of the first electrode-tissue contact group in accordance with corresponding stimulation modes; control the electrostimulator to provide clinical electrostimulation energy to the selected neural target in accordance with the corresponding stimulation mode as taught by Block et al, since such a modification would provide the predictable results of improved therapy programming precision by optimizing the target neuromodulation field based on the patient’s anatomy, electrode position, and various neural structures thereby resulting in better therapeutic outcome.
Referring to Claims 2 and 15, Li et al in view of Block et al teaches the claimed invention, wherein the electrostimulator is coupled to the lead system placed at or near a spinal cord of the patient (e.g. Figure 2), wherein the controller circuit is configured to determine the distinct electrode-tissue contact groups based at least in part on locations of spinal neural targets with respect to one or more spinal cord levels (e.g. Paragraphs [0021]-[0022]).
Referring to Claim 3, Li et al in view of Block et al teaches the neuromodulation system of claim 2, wherein the distinct electrode-tissue contact groups includes at least one group comprising one or more lateral spinal neural targets (e.g. Paragraphs [0007] and [0014] and Figure 6).
Referring to Claim 4, Li et al in view of Block et al teaches the neuromodulation system of claim 3, wherein the one or more lateral spinal neural targets include at least one of: a dorsal root entry zone, a Lissauer's track, a dorsal root, a dorsal rootlet, or a dorsal root ganglion (e.g. Paragraph [0006]).
Referring to Claims 5-6 and 16, Li et al in view of Block et al teaches the claimed invention, discloses using the controller circuit to set stimulation parameters that best address the painful site (e.g. Paragraph [0009]). However, Li et al does not explicitly disclose wherein the controller circuit is configured to determine the distinct electrode-tissue contact groups based at least in part on information about pain perception of the patient; wherein the information about pain perception includes an identification of pain areas corresponding to one or more dermatomes.
Block et al teaches that it is known to use wherein the controller circuit is configured to determine the distinct electrode-tissue contact groups based at least in part on information about pain perception of the patient; wherein the information about pain perception includes an identification of pain areas corresponding to one or more dermatomes as set forth in Paragraphs [0116], [0125]-[0126] to provide improved pain management and the avoidance of stimulation in unafflicted regions. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Li et al, with the controller circuit is configured to determine the distinct electrode-tissue contact groups based at least in part on information about pain perception of the patient; wherein the information about pain perception includes an identification of pain areas corresponding to one or more dermatomes as taught by Block et al, since such a modification would provide the predictable results of improved pain management and the avoidance of stimulation in unafflicted regions.
Referring to Claims 7 and 17, Li et al in view of Block et al teaches the claimed invention, comprising a display to distinguishably display the distinct electrode-tissue contact groups (e.g. Figure 5, Element 76 and Figure 7).
Referring to Claim 8, Li et al in view of Block et al teaches the neuromodulation system of claim 7, wherein to distinguishably display the distinct electrode-tissue contact groups includes to display the distinct electrode-tissue contact groups in different colors or renders (e.g. Figure 7).
Referring to Claims 9 and 18, Li et al in view of Block et al teaches the claimed invention, comprising a user interface configured to receive a user input of the stimulation mode for the at least one of the distinct electrode-tissue contact groups (e.g. Paragraph [0021] and Figure 7, element 100).
Referring to Claim 10, Li et al in view of Block et al teaches the neuromodulation system of claim 1, wherein to determine the stimulation mode includes to select from candidate stimulation modes comprising a paresthesia-based stimulation mode and a paresthesia-free stimulation mode (e.g. Paragraph [0006]-[0009]).
Referring to Claim 11, Li et al in view of Block et al teaches the neuromodulation system of claim 1, wherein to determine the stimulation mode includes to select from candidate stimulation modes comprising a monopolar stimulation mode and a bipolar stimulation mode (e.g. Paragraph [0005]).
Referring to Claims 12, 13, 19 and 20, Li et al in view of Block et al teaches the claimed invention, wherein the identified distinct electrode-tissue contact groups include a first electrode-tissue contact group comprising two or more neural targets, wherein the controller circuit is configured to determine respective stimulation modes for stimulating the two or more neural targets of the first electrode-tissue contact group;
select a neural target from the two or more neural targets based on patient responses to test neuromodulation energy individually and independently delivered to the two or more neural targets of the first electrode-tissue contact group in accordance with corresponding stimulation modes; control the electrostimulator to provide clinical electrostimulation energy to the selected neural target in accordance with the corresponding stimulation mode.
Block et al teaches that it is known to use the controller selecting neural structures individually on a patient and across different neural structures (e.g. dorsal roots and dorsal root ganglia) to as set forth in Figure 21 and Paragraphs [0118] and [0135] to provide improved therapy programming precision by optimizing the target neuromodulation field based on the patient’s anatomy, electrode position, and various neural structures thereby resulting in better therapeutic outcome. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Li et al, with the identified distinct electrode-tissue contact groups include a first electrode-tissue contact group comprising two or more neural targets, wherein the controller circuit is configured to determine respective stimulation modes for stimulating the two or more neural targets of the first electrode-tissue contact group; select a neural target from the two or more neural targets based on patient responses to test neuromodulation energy individually and independently delivered to the two or more neural targets of the first electrode-tissue contact group in accordance with corresponding stimulation modes; control the electrostimulator to provide clinical electrostimulation energy to the selected neural target in accordance with the corresponding stimulation mode as taught by Block et al, since such a modification would provide the predictable results of improved therapy programming precision by optimizing the target neuromodulation field based on the patient’s anatomy, electrode position, and various neural structures thereby resulting in better therapeutic outcome.
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.
Claims 5, 9, 13, 16, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of U.S. Patent No. 12,194,298. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ranu (US Publication 2016/0220823) discloses a neurostimulation which uses image recognition to a stored medical image to automatically determine longitudinal location (e.g. Paragraph [0072]) and based on the longitudinal location adjusting the stimulation amplitudes (e.g. Paragraph [0077]).
Torgerson (US Publication 2019/0366096) teaches a neurostimulation device that obtains the placement of the leads and determine electrode combinations for delivery of stimulation to the patient (e.g. Paragraphs [0065], [0067], [0078], and claim 6)
Polefko et al (US Publication 2013/0060299) discloses an SCS (neurostimulation system) where the programmer associates the area based on an image of a spinal column and determining an expected stimulation field based on the positioning input (e.g. Paragraph [0078] and claim 5)
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
