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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,129,989. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the Patent discloses a plurality of first pulses (control) interleaved with a plurality of second pulses (informed pulses); and sensing ECAPs after the first pulses and not the second pulses (“sensing, after one or more control pulses…and prior to an immediately subsequent informed pulse…an evoked compound action potential (ECAP)”). Claims 6 and 7 of the Patent, which depend form claim 1 discloses comparing the ECAP to a threshold value (an amplitude threshold) and adjusting a parameter value (an amplitude) in response to the ECAP exceeding the threshold value (Claim 7). Claim 1 discloses delivering the adjusted therapy values after the detecting the first ECAP.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,129,991 in view of Jaax (PGPUB 2014/0277282). Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1 and 7 of the Patent discloses a plurality of first pulses (control pulses) interleaved with a plurality of second pulses (infromed pulses), see Claim 7; and sensing ECAPs after the first pulses and not the second pulses (“sensing an evoked compound action potential (ECAP) signal elicited by the control stimulation pulse”). The claims differ in that the Patent does not require comparison of a value of the ECAP to various thresholds. However, Jaax discloses a similar system that contains this feature (comparing ECAPs to upper and lower thresholds) for the purpose of determining when and how to adjust stimulation to maintain the ECAP within a desired threshold range (Fig. 5, par. [0064-0068]). Therefore 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 device in U.S. Patent 11,129,991 reference to include comparing the ECAP to various thresholds, as taught and suggested by Jaax, for the purpose of maintaining the ECAP within a desired threshold range.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,931,582. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the Patent discloses a plurality of first pulses (control pulses) interleaved with a plurality of second pulses (informed pulses); sensing ECAPs after the first pulses and not the second pulses (“sensing circuitry configured to detect a plurality of evoked compound action potentials (ECAPs) elicited by respective pulses of the plurality of control pulses instead of any ECAPs elicited by any informed pulses”); comparing the ECAP value to a first threshold; determining if the ECAP is above the threshold; and adjusting stimulation when the value is above the threshold (see the steps starting “determine that a first value…”; “responsive to determining that the first value…”; and “control; the stimulation generation circuitry…”).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,023,501 in view of Jaax (PGPUB 2014/0277282). Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1 and 11 of the Patent discloses a plurality of first pulses (control pulses) interleaved with a plurality of second pulses (informed pulses); and sensing ECAPs after the first pulses and not the second pulses (“receive a sensed…(ECAP) signal elicited by the first control stimulation pulse”). The claims differ in that the Patent does not require comparison of a value of the ECAP to various thresholds. However, Jaax discloses a similar system that contains this feature (comparing ECAPs to upper and lower thresholds) for the purpose of determining when and how to adjust stimulation to maintain the ECAP within a desired threshold range (Fig. 5, par. [0064-0068]). Therefore, 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 device in U.S. Patent 12,023,501 reference to include comparing the ECAP to various thresholds, as taught and suggested by Jaax, for the purpose of maintaining the ECAP within a desired threshold range.
Claims 1-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,133,982. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1 and 8 of the Patent discloses a plurality of first pulses (control pulses) interleaved with a plurality of second pulses (informed pulses); sensing ECAPs after the first pulses and not the second pulses (“receive a sensed respective…(ECAP) after one or more control pulses…and prior to a subsequent informed pulse”); comparing the ECAP value to a first threshold (“compare the representative amplitude…to a target ECAP amplitude”, claim 8); determining if the ECAP is above the threshold; and adjusting stimulation when the value is above the threshold (see the step starting “wherein adjusting…” in claim 8).
Claims 1-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,011,595. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1 and 9 of the Patent discloses a plurality of first pulses (control pulses) interleaved with a plurality of second pulses (informed pulses); sensing ECAPs after the first pulses and not the second pulses (“sensing circuitry configured to sense an…ECAP signal elicited by a control stimulation pulse”); comparing the ECAP value to a first threshold (“comparing the characteristic value of the ECAP signal to a threshold ECAP characteristic value”, claim 9); determining if the ECAP is above the threshold; and adjusting stimulation when the value is above the threshold (the remainder of claim 9).
Claims 1-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,357,830. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the Patent discloses a plurality of first pulses (control pulses) interleaved with a plurality of second pulses (therapy pulses); sensing ECAPs after the first pulses and not the second pulses (“sensing circuitry configured to sense…ECAP signals elicited by the plurality of control pulses instead of the plurality of therapy pulses”); comparing the ECAP value to a first threshold (a value that results in a desired stimulation threshold); determining if the ECAP is above the threshold; and adjusting stimulation when the value is above the threshold (Claims 7, 8).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim recites “a computer readable medium” which encompasses both transitory (signals per se) and non-transitory forms of storage media. Signals per se are not patent eligible. To overcome the current rejection, the Examiner suggests amending the claim to read “ a non-transitory computer readable medium”.
Allowable Subject Matter
The Examiner notes that no claims are currently in condition for allowance due to the double patenting rejections and the 35 USC 101 rejection. However, the Examiner also notes that the claims are not rejected under art and the claims overcome the closest art of Jaax (PGPUB 2014/0277282) for the following reasons which were noted by Applicant in the response dated 5/17/2023 in parent application 17/066219:
Jaax discloses that "[t]he electrical pulse parameter is incrementally increased or decreased until the magnitude of the measured eCAP is at the optimum value within the threshold range. That is, electrical stimulation energy is delivered to the first set of the electrodes 26 in accordance with the set of stimulation parameters." Jaax does not disclose or suggest "stimulation generation circuitry configured to deliver electrical stimulation to a patient, wherein the electrical stimulation comprises a plurality of control pulses and a plurality of informed pulses, the plurality of control pulses at least partially interleaved with the plurality of informed pulses" and "sensing circuitry configured to detect a plurality of evoked compound action potentials (ECAPs) elicited by respective pulses of the plurality of first pulses instead of any ECAPs elicited by any second pulses of the plurality of second pulses," wherein the first and second plurality of pulses are at least partially interleaved as recited by independent claims 1, 11 and 20.
Upon overcoming the double patenting rejections with the appropriately field Terminal Disclaimers and overcoming the 35 USC 101 rejection with the suggested amendment, the claims would be in condition for allowance.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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