CTNF 18/886,436 CTNF 87965 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 101 07-04-03 Claims 2-4 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claims 2-4 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 2-4 are rejected under 35 U.S.C. 101 because it is drawn to non-statutory subject matter. Applicant recites part of a human, i.e. "…lead system placed at or near a spina cord of the patient…”(Claim 2, lines 1-2). Thus, these claims include a human within the scope and are non-statutory. The examiner suggests using the phrase "adapted to be located" when referring to the location of the lead system in relation to the spinal cord of the patient. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1-4, 7-11, 14-15, and 17-18 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Li et al (US Publication 2015/0119958) . 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 placed at 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). Referring to Claims 2 and 15, Li 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 o ne or more spinal cord levels (e.g. Paragraphs [0021]-[0022]). Referring to Claim 3, Li 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 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 7 and 17, Li 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 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 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 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 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]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 5-6, 12-13, 16 and 19-20 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 5-6 and 16, Li 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 12, 13, 19 and 20, Li 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 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 AIA Claim s 5, 9, 13, 16, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 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 07-96 AIA 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) 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. 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, 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. 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. /William J Levicky/Primary Examiner, Art Unit 3796 Application/Control Number: 18/886,436 Page 2 Art Unit: 3796 Application/Control Number: 18/886,436 Page 3 Art Unit: 3796 Application/Control Number: 18/886,436 Page 4 Art Unit: 3796 Application/Control Number: 18/886,436 Page 5 Art Unit: 3796 Application/Control Number: 18/886,436 Page 6 Art Unit: 3796 Application/Control Number: 18/886,436 Page 7 Art Unit: 3796 Application/Control Number: 18/886,436 Page 8 Art Unit: 3796 Application/Control Number: 18/886,436 Page 9 Art Unit: 3796
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