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 .
Specification
The disclosure is objected to because of the following informalities: The first paragraph of the specification should be updated to include any issued patent numbers.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
1) In Claims 1 and 13, line 4, “the plurality of control stimulation pulses” lacks clear antecedence and is an incomplete sentence.
Claim Rejections - 35 USC § 102
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 –
(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.
Claims 1-4, 6, 11-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018080754 by Torgerson.
Regarding Claim 1, Torgerson discloses a system comprising:
stimulation generation circuitry (e.g. ¶¶ 16, 93, and Fig. 2: stimulation generator 202) configured to:
deliver a first primary stimulation pulse of a plurality of primary stimulation pulses to a patient, the plurality of control stimulation pulses (e.g. ¶¶ 7,37,42-45: “pulses having a second amplitude” capable of evoking actions potentials are intermingled within trains of therapeutic pulses of lower first amplitude; ¶¶ 168-170 and Fig. 8-9: as examples, second amplitude larger pulses 812/816/820/828 and 912/916/920/924/928 correspond to the claimed primary stimulation pulses; In the interest of clarity, the pulses of a “second” larger amplitude of Torgerson meet and correspond to the claimed “primary” stimulation pulses of the claim, the term “primary” being a nominal tag devoid of any further meaning and absent from the specification); and
deliver a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (e.g. ¶¶ 7,42-45: “pulses having the first amplitude”, ie. the therapeutic subthreshold lower amplitude pulse trains meet the “secondary stimulation pulse” claimed; ¶¶ 168-170 and Fig. 8-9: as examples, first amplitude pulses 810/814/818/822/826/830 and 910/914/918/922/926/930 correspond to the claimed secondary stimulation pulses; In the interest of clarity, the pulses of a “first” lower amplitude of Torgerson meet and correspond to the claimed “secondary” stimulation pulses of the claim, the term “secondary” being a nominal tag devoid of any further meaning and absent from the specification); and
processing circuitry (e.g. ¶¶ 8,93 and Fig. 2: control processor 210) configured to:
receive a sensed evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse (e.g. ¶¶ 4-5,7,53,79,168-170: eCAP is received via sensors, and the action potential evoked by the pulses having a second larger amplitude includes eCAP);
identify a characteristic of the ECAP signal (e.g. ¶¶ 79, 84, 110: eCAP is measured, its presence is detected and the magnitude of stimulation pulses that cause it are recorded. Thus, each of the measurement of the eCAP, the detection of its presence, and the stimulation pulse that causes it meet a “characteristic of the eCAP signal”);
determine, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses (e.g. abstract, ¶¶ 4-5,35-45,84,118,163: the subsequent pulses, both of the first amplitude and the second amplitude are adjusted based on: a) the presence or absence of an eCAP, ie. eCAP characteristics, b) the magnitude of the previous “second amplitude” pulses that caused the eCAP, also an eCAP characteristic, and c) a percentage increase or decrease, ie. gain, in relation to the previous pulse that caused the eCAP or did not cause the eCAP; Also see Fig. 6, steps 606, 608 and 610);
determine a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (e.g. ¶¶ 37-40,44-45,77,84,118,163: the ratio between the second amplitude pulses and the first amplitude pulses is a “set ratio” and the first and second amplitudes are “set relative to one another”, thus changing one changes the other proportionally, and this is done in response to eCAPs being present or absent after the previous second amplitude pulses are fired); and
control the stimulation generation circuitry to deliver the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (e.g. ¶¶ 44-45,56,77,84,118,163: the adjustment to the therapeutic lower amplitude pulses follows, with a set ratio, the action potential stimulating second amplitude pulses without suspending stimulation due to the eCAP).
Regarding Claim 2, Torgerson discloses the system of claim 1, wherein the stimulation generation circuitry is configured to deliver the plurality of primary stimulation pulses at a first frequency over a period of time, and wherein the first frequency is within a range from 50 Hz to 400 Hz (e.g. ¶ 43-44: 150 Hz).
Regarding Claim 3, Torgerson discloses the system of claim 2, wherein the first frequency is within a range from 50 Hz to 60 Hz (e.g. ¶ 43-44: 50 Hz).
Regarding Claim 4, Torgerson discloses the system of claim 2, wherein the stimulation generation circuitry is configured to deliver the plurality of secondary stimulation pulses at a second frequency over the period of time, and wherein the second frequency is greater than 400 Hz (e.g. ¶43: 10 kHz).
Regarding Claim 6, Torgerson discloses the system of claim 1, wherein a second pulse width of the plurality of secondary stimulation pulses is less than a first pulse width of the plurality of primary stimulation pulses (e.g. ¶ 51: second amplitude pulses are wider).
Regarding Claim 11, Torgerson discloses the system of claim 1, wherein the processing circuitry is configured to interleave the plurality of primary stimulation pulses with at least some of the plurality of secondary stimulation pulses (e.g. ¶ 7, Fig. 8-9: the two types of pulses are intermingled).
Regarding Claim 12, Torgerson discloses the system of claim 11, wherein to interleave the plurality of primary stimulation pulses within at least some of the plurality of secondary stimulation pulses, the processing circuitry is configured to: deliver at least two secondary stimulation pulses of the plurality of secondary stimulation pulses between consecutive primary stimulation pulses; and sense, between the consecutive secondary stimulation pulses, the ECAP signal elicited by the primary stimulation pulse delivered between the consecutive secondary stimulation pulses (e.g. ¶ 43: 200 first amplitude pulses between second amplitude pulses).
Regarding Claim 13, Torgerson teaches a method comprising:
delivering a first primary stimulation pulse of a plurality of first primary stimulation pulses to a patient, the plurality of control stimulation pulses (e.g. ¶¶ 7,42-45: “pulses having a second amplitude” capable of evoking actions potentials are intermingled within trains of therapeutic pulses of lower first amplitude; ¶¶ 168-170 and Fig. 8-9: as examples, second amplitude larger pulses 812/816/820/828 and 912/916/920/924/928 correspond to the claimed primary stimulation pulses; In the interest of clarity, the pulses of a “second” larger amplitude of Torgerson meet and correspond to the claimed “primary” stimulation pulses of the claim, the term “primary” being a nominal tag devoid of any further meaning and absent from the specification);
delivering a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (e.g. ¶¶ 7,42-45: “pulses having the first amplitude”, ie. the therapeutic subthreshold lower amplitude pulse trains meet the “secondary stimulation pulse” claimed; ¶¶ 168-170 and Fig. 8-9: as examples, first amplitude pulses 810/814/818/822/826/830 and 910/914/918/922/926/930 correspond to the claimed secondary stimulation pulses; In the interest of clarity, the pulses of a “first” lower amplitude of Torgerson meet and correspond to the claimed “secondary” stimulation pulses of the claim, the term “secondary” being a nominal tag devoid of any further meaning and absent from the specification);
sensing an evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse (e.g. ¶¶ 4-5,7,53,79,168-170: eCAP is sensed via sensors, and the action potential evoked by the pulses having a second larger amplitude includes eCAP);
identifying a characteristic of the ECAP signal (e.g. ¶¶ 79, 84, 110: eCAP is measured, its presence is detected and the magnitude of stimulation pulses that cause it are recorded. Thus, each of the measurement of the eCAP, the detection of its presence, and the stimulation pulse that causes it meet a “characteristic of the eCAP signal”);
determining, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses (e.g. abstract, ¶¶ 4-5,35-45,84,118,163: the subsequent pulses, both of the first amplitude and the second amplitude are adjusted based on: a) the presence or absence of an eCAP, ie. eCAP characteristics, b) the magnitude of the previous “second amplitude” pulses that caused the eCAP, also an eCAP characteristic, and c) a percentage increase or decrease, ie. gain, in relation to the previous pulse that caused the eCAP or did not cause the eCAP; Also see Fig. 6, steps 606, 608 and 610);
determining a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (e.g. ¶¶ 44-45,77,84,118,163: the ratio between the second amplitude pulses and the first amplitude pulses is a “set ratio” and the first and second amplitudes are “set relative to one another”, thus changing one changes the other proportionally, and this is done in response to eCAPs being present or absent after the previous second amplitude pulses are fired); and
delivering the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (e.g. ¶¶ 44-45,56,77,84,118,163: the adjustment to the therapeutic lower amplitude pulses follows, with a set ratio, the action potential stimulating second amplitude pulses without suspending stimulation due to the eCAP).
Regarding Claim 14, Torgerson discloses the method of claim 13, further comprising delivering the plurality of primary stimulation pulses at a first frequency over a period of time, wherein the first frequency is within a range from 50 Hz to 400 Hz (e.g. ¶ 43-44: 50 Hz).
Regarding Claim 15, Torgerson discloses the method of claim 14, wherein the first frequency is within a range from 50 Hz to 60 Hz (e.g. ¶ 43-44: 50 Hz).
Regarding Claim 16, Torgerson discloses the method of claim 15, further comprising delivering the plurality of secondary stimulation pulses at a second frequency over the period of time, wherein the second frequency is greater than 400 Hertz (Hz) (e.g. ¶ 43-44: 10 kHz)).
Regarding Claim 18, Torgerson discloses the method of claim 13, wherein a second pulse width of the plurality of secondary stimulation pulses is less than a first pulse width of the plurality of primary stimulation pulses (¶51).
Regarding Claim 19, Torgerson discloses the method of claim 13, further comprising interleaving the plurality of primary stimulation pulses with at least some secondary stimulation pulses of the plurality of secondary stimulation pulses such that at least one secondary stimulation pulse of the plurality of secondary stimulation pulses are delivered between consecutive primary stimulation pulses of the plurality of primary stimulation pulses (e.g. ¶ 7, Fig. 8-9: the two types of pulses are intermingled).
Regarding Claim 20, Torgerson discloses a non-transitory computer-readable storage medium (e.g. ¶¶ 18, 93: CRM 211) comprising instructions that, when executed, causes one or more processors to:
control delivery of a first primary stimulation pulse of a plurality of first primary stimulation pulses to a patient (e.g. ¶¶ 7,42-45: “pulses having a second amplitude” capable of evoking actions potentials are intermingled within trains of therapeutic pulses of lower first amplitude; ¶¶ 168-170 and Fig. 8-9: as examples, second amplitude larger pulses 812/816/820/828 and 912/916/920/924/928 correspond to the claimed primary stimulation pulses; In the interest of clarity, the pulses of a “second” larger amplitude of Torgerson meet and correspond to the claimed “primary” stimulation pulses of the claim, the term “primary” being a nominal tag devoid of any further meaning and absent from the specification);
control delivery of a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (e.g. ¶¶ 7,42-45: “pulses having the first amplitude”, ie. the therapeutic subthreshold lower amplitude pulse trains meet the “secondary stimulation pulse” claimed; ¶¶ 168-170 and Fig. 8-9: as examples, first amplitude pulses 810/814/818/822/826/830 and 910/914/918/922/926/930 correspond to the claimed secondary stimulation pulses; In the interest of clarity, the pulses of a “first” lower amplitude of Torgerson meet and correspond to the claimed “secondary” stimulation pulses of the claim, the term “secondary” being a nominal tag devoid of any further meaning and absent from the specification);
sense an evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse (e.g. ¶¶ 4-5,7,53,79,168-170: eCAP is sensed via sensors, and the action potential evoked by the pulses having a second larger amplitude includes eCAP);
identify a characteristic of the ECAP signal (e.g. ¶¶ 79, 84, 110: eCAP is measured, its presence is detected and the magnitude of stimulation pulses that cause it are recorded. Thus, each of the measurement of the eCAP, the detection of its presence, and the stimulation pulse that causes it meet a “characteristic of the eCAP signal”);
determine, based on the characteristic of the ECAP signal and a gain value, a second amplitude that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses (e.g. abstract, ¶¶ 4-5,35-45,84,118,163: the subsequent pulses, both of the first amplitude and the second amplitude are adjusted based on: a) the presence or absence of an eCAP, ie. eCAP characteristics, b) the magnitude of the previous “second amplitude” pulses that caused the eCAP, also an eCAP characteristic, and c) a percentage increase or decrease, ie. gain, in relation to the previous pulse that caused the eCAP or did not cause the eCAP; Also see Fig. 6, steps 606, 608 and 610);
determine a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (e.g. ¶¶ 44-45,77,84,118,163: the ratio between the second amplitude pulses and the first amplitude pulses is a “set ratio” and the first and second amplitudes are “set relative to one another”, thus changing one changes the other proportionally, and this is done in response to eCAPs being present or absent after the previous second amplitude pulses are fired); and
control delivery of the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (e.g. ¶¶ 44-45,56,77,84,118,163: the adjustment to the therapeutic lower amplitude pulses follows, with a set ratio, the action potential stimulating second amplitude pulses without suspending stimulation due to the eCAP).
Claim Rejections - 35 USC § 103
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.
Claims 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson, as applied to Claims 4 and 16, respectively.
Regarding Claims 5 and 17, Torgerson discloses the system of claims 4 and 16, wherein the second frequency is within the range of less than 1000 Hz, or less than 1500 Hz and greater than 200 Hz (¶110), yet does not explicitly disclose that the second frequency is within a range from 900 Hz to 1200 Hz. However, the working ranges in Torgerson overlap with the claimed ranges. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select a frequency within a range from 900 to 1200 Hz for the second frequency, in a device and method according to the teachings of Torgerson, as according to MPEP 2144.05.I, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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 1-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19, respectively, of U.S. Patent No. 12,023,501. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1-19 of the issued patent are near identical to and anticipate respective Claims 1-18, and 20 of the instant application, the differences being that: a) “control” stimulation pulses have been replaced by “primary” stimulation pulses, b) “informed” stimulation pulses have been replaced by “secondary” stimulations pulses, and c) the issued patent includes additional limitations, such as the frequencies. Said replacements are broadening, thus the Claims of the issued patent clearly anticipate the claims of the instant application.
Regarding Claim 1, Claim 1 of the issued patent discloses a system comprising: stimulation generation circuitry configured to: deliver a first primary stimulation pulse of a plurality of primary stimulation pulses to a patient, the plurality of control stimulation pulses; and deliver a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (Claim 1: A system comprising: stimulation generation circuitry configured to: deliver a first control stimulation pulse of a plurality of control stimulation pulses to a patient, the plurality of control stimulation pulses comprising a first frequency; and deliver a first informed stimulation pulse of a plurality of informed stimulation pulses to the patient, the plurality of informed stimulation pulses comprising a second frequency different than the first frequency); and processing circuitry configured to: receive a sensed evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse; identify a characteristic of the ECAP signal; determine, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses; determine a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (Claim 1: processing circuitry configured to: receive a sensed evoked compound action potential (ECAP) signal elicited by the first control stimulation pulse; identify a characteristic of the ECAP signal; determine, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second informed stimulation pulse of the plurality of informed stimulation pulses; determine a second amplitude value that at least partially defines a second control stimulation pulse of the plurality of control stimulation pulses to maintain a first ratio of a first amplitude value of the first control stimulation pulse to a first amplitude value of the first informed stimulation pulse being equal to a second ratio of the second amplitude value of the second control stimulation pulses to the second amplitude value of the second informed stimulation pulses); and control the stimulation generation circuitry to deliver the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (Claim 1: control the stimulation generation circuitry to deliver the second control stimulation pulse according to the second amplitude value that at least partially defines the second control stimulation pulse and the second informed stimulation pulse of the plurality of informed stimulation pulses according to the second amplitude value that at least partially defines the second informed pulse).
Regarding Claim 2, Claim 2 of the issued patent discloses the system of claim 1, wherein the stimulation generation circuitry is configured to deliver the plurality of primary stimulation pulses at a first frequency over a period of time, and wherein the first frequency is within a range from 50 Hz to 400 Hz (Claim 2: the stimulation generation circuitry is configured to deliver the plurality of control stimulation pulses at the first frequency over a period of time, and wherein the first frequency is within a range from 50 Hz to 400 Hz).
Regarding Claim 3, Claim 3 of the issued patent discloses the system of claim 2, wherein the first frequency is within a range from 50 Hz to 60 Hz (Claim 3: wherein the first frequency is within a range from 50 Hz to 60 Hz).
Regarding Claim 4, Claim 4 of the issued patent discloses the system of claim 2, wherein the stimulation generation circuitry is configured to deliver the plurality of secondary stimulation pulses at a second frequency over the period of time, and wherein the second frequency is greater than 400 Hz (Claim 4: same limitations, verbatim, same claim dependency).
Regarding Claim 5, Claim 5 of the issued patent discloses the system of claim 4, wherein the second frequency is within a range from 900 Hz to 1200 Hz (Claim 5: same limitations, verbatim, same claim dependency).
Regarding Claim 6, Claim 6 of the issued patent discloses the system of claim 1, wherein a second pulse width of the plurality of secondary stimulation pulses is less than a first pulse width of the plurality of primary stimulation pulses (Claim 6: same limitations, verbatim, same claim dependency).
Regarding Claim 7, Claim 7 of the issued patent discloses the system of claim 1, wherein the gain value represents a slope of a growth curve of values of the characteristic of ECAP signals elicited from respective calibration stimulation pulses delivered to the patient and at least partially defined by different values of a stimulation parameter (Claim 7: same limitations, verbatim, same claim dependency).
Regarding Claim 8, Claim 8 of the issued patent discloses the system of claim 1, wherein the characteristic of the ECAP signal is a measured amplitude of a portion of the ECAP signal, wherein to determine the second amplitude value of the second secondary stimulation pulse, the processing circuitry is configured to: subtract the measured amplitude from a target ECAP amplitude value for the patient to generate a differential amplitude; multiply the differential amplitude by the gain value to generate a preliminary differential value; multiply the preliminary differential value by a scaling factor to generate a scaled differential value, wherein the scaling factor represents the first ratio; and add the scaled differential value to the first amplitude value of the first secondary stimulation pulse to generate the second amplitude value that at least partially defines the second secondary stimulation pulse (Claim 8: same limitations, verbatim, same claim dependency).
Regarding Claim 9, Claim 9 of the issued patent discloses the system of claim 8, wherein the measured amplitude of the portion of the ECAP signal comprises a voltage amplitude between an N1 peak and a P2 peak of the ECAP signal (Claim 9: same limitations, verbatim, same claim dependency).
Regarding Claim 10, Claim 10 of the issued patent discloses the system of claim 1, wherein to determine, based on the characteristic of the ECAP signal and the gain value, the second amplitude value that at least partially defines the second secondary stimulation pulse, the processing circuitry is configured to: determine, based on an average value of a characteristic of a plurality of consecutively sensed ECAP signals and the gain value, the second amplitude value that at least partially defines the second secondary stimulation pulse, the plurality of consecutively sensed ECAP signals comprising the ECAP signal (Claim 10: same limitations, verbatim, same claim dependency).
Regarding Claim 11, Claim 11 of the issued patent discloses the system of claim 1, wherein the processing circuitry is configured to interleave the plurality of primary stimulation pulses with at least some of the plurality of secondary stimulation pulses (Claim 11: same limitations, verbatim, same claim dependency).
Regarding Claim 12, Claim 12 of the issued patent discloses the system of claim 11, wherein to interleave the plurality of primary stimulation pulses within at least some of the plurality of secondary stimulation pulses, the processing circuitry is configured to: deliver at least two secondary stimulation pulses of the plurality of secondary stimulation pulses between consecutive primary stimulation pulses; and sense, between the consecutive secondary stimulation pulses, the ECAP signal elicited by the primary stimulation pulse delivered between the consecutive secondary stimulation pulses (Claim 12: same limitations, verbatim, same claim dependency).
Regarding Claim 13, Claim 13 of the issued patent discloses a method comprising: delivering a first primary stimulation pulse of a plurality of first primary stimulation pulses to a patient, the plurality of control stimulation pulses; delivering a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (Claim 13: A method comprising: delivering a first control stimulation pulse of a plurality of control stimulation pulses to a patient, the plurality of control stimulation pulses comprising a first frequency; delivering a first informed stimulation pulse of a plurality of informed stimulation pulses to the patient, the plurality of informed stimulation pulses comprising a second frequency different than the first frequency); sensing an evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse; identifying a characteristic of the ECAP signal; determining, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses; determining a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (Claim 13: sensing an evoked compound action potential (ECAP) signal elicited by the first control stimulation pulse; identifying a characteristic of the ECAP signal; determining, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second informed stimulation pulse of the plurality of informed stimulation pulses; determining a second amplitude value that at least partially defines a second control stimulation pulse of the plurality of control pulses to maintain a first ratio of a first amplitude value of the first control stimulation pulse to a first amplitude value of the first informed stimulation pulse being equal to a second ratio of the second amplitude value of the second control stimulation pulses to the second amplitude value of the second informed stimulation pulses); and delivering the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (Claim 13: delivering the second control stimulation pulse according to the second amplitude value that at least partially defines the second control stimulation pulse and the second informed stimulation pulse of the plurality of informed stimulation pulses according to the second amplitude value that at least partially defines the second informed pulse).
Regarding Claim 14, Claim 14 of the issued patent discloses the method of claim 13, further comprising delivering the plurality of primary stimulation pulses at a first frequency over a period of time, wherein the first frequency is within a range from 50 Hz to 400 Hz (Claim 14: same limitations, verbatim, same claim dependency).
Regarding Claim 15, Claim 15 of the issued patent discloses the method of claim 14, wherein the first frequency is within a range from 50 Hz to 60 Hz (Claim 15: same limitations, verbatim, same claim dependency).
Regarding Claim 16, Claim 16 of the issued patent discloses the method of claim 15, further comprising delivering the plurality of secondary stimulation pulses at a second frequency over the period of time, wherein the second frequency is greater than 400 Hertz (Hz) (Claim 16: same limitations, verbatim, same claim dependency).
Regarding Claim 17, Claim 17 of the issued patent discloses the method of claim 16, wherein the second frequency is within a range from 900 Hz to 1200 Hz (Claim 17: same limitations, verbatim, same claim dependency).
Regarding Claim 18, Claim 18 of the issued patent discloses the method of claim 13, wherein a second pulse width of the plurality of secondary stimulation pulses is less than a first pulse width of the plurality of primary stimulation pulses (Claim 18: same limitations, verbatim, same claim dependency).
Regarding Claim 20, Claim 19 of the issued patent discloses a non-transitory computer-readable storage medium comprising instructions that, when executed, causes one or more processors to: control delivery of a first primary stimulation pulse of a plurality of first primary stimulation pulses to a patient; control delivery of a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (Claim 19: A non-transitory computer-readable storage medium comprising instructions that, when executed, causes one or more processors to: control delivery of a first control stimulation pulse of a plurality of control stimulation pulses to a patient, the plurality of control stimulation pulses comprising a first frequency; control delivery of a first informed stimulation pulse of a plurality of informed stimulation pulses to the patient, the plurality of informed stimulation pulses comprising a second frequency different than the first frequency); sense an evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse; identify a characteristic of the ECAP signal; determine, based on the characteristic of the ECAP signal and a gain value, a second amplitude that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses; determine a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (Claim 19: sense an evoked compound action potential (ECAP) signal elicited by the first control stimulation pulse; identify a characteristic of the ECAP signal; determine, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second informed stimulation pulse of the plurality of informed stimulation pulses; determine a second amplitude value that at least partially defines a second control stimulation pulse of the plurality of control stimulation pulses to maintain a first ratio of a first amplitude value of the first control stimulation pulse to a first amplitude value of the first informed stimulation pulse being equal to a second ratio of the second amplitude value of the second control stimulation pulses to the second amplitude value of the second informed stimulation pulses); and control delivery of the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (Claim 19: control delivery of the second control stimulation pulse according to the second amplitude value that at least partially defines the second control stimulation pulse and the second informed stimulation pulse of the plurality of informed stimulation pulses according to the second amplitude value that at least partially defines the second informed pulse).
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 12,023,501, in view of Torgerson.
Regarding Claim 19, Claim 13 of the issued patent discloses the method of claim 13 (Claim 13: same limitations, verbatim), yet does not disclose further comprising interleaving the plurality of primary stimulation pulses with at least some secondary stimulation pulses of the plurality of secondary stimulation pulses such that at least one secondary stimulation pulse of the plurality of secondary stimulation pulses are delivered between consecutive primary stimulation pulses of the plurality of primary stimulation pulses. However, Torgerson teaches an analogous stimulation method, comprising interleaving the plurality of primary stimulation pulses with at least some secondary stimulation pulses of the plurality of secondary stimulation pulses such that at least one secondary stimulation pulse of the plurality of secondary stimulation pulses are delivered between consecutive primary stimulation pulses of the plurality of primary stimulation pulses (e.g. ¶¶ 6,7,32,44,55 Fig. 8-9: the two types of pulses are intermingled as this enables continuity in stimulation under different circumstances, e.g. posture change). Therefore, it would have been obvious to a person having ordinary skill in the art before to interleave the primary with the secondary pulses in a method according to the teachings of Claim 13 of the issued patent, as taught by Torgerson, in order to predictably titrate stimulation, and this would further enable continuity in stimulation without interruptions due to changes caused by position or posture changes, as suggested by Torgerson.
Claims 1-6, 13-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 14-17 and 19-20, respectively, 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 1-6, 14-17 and 19-20 of the issued patent are near identical to and anticipate respective Claims 1-6, 13-18 and 20 of the instant application, as follows:
Regarding Claim 1, Claim 1 of the issued patent discloses a system comprising: stimulation generation circuitry configured to: deliver a first primary stimulation pulse of a plurality of primary stimulation pulses to a patient, the plurality of control stimulation pulses and deliver a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (Claim 1: A system comprising: stimulation generation circuitry configured to: deliver electrical stimulation therapy to a patient, wherein the electrical stimulation therapy comprises a plurality of informed pulses at a first frequency over a period of time; and deliver a plurality of control pulses at a second frequency different than the first frequency over the period of time); and processing circuitry configured to: receive a sensed evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse; identify a characteristic of the ECAP signal; determine, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses; determine a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (Claim 1: processing circuitry configured to: receive a sensed respective evoked compound action potential (ECAP) after one or more control pulses of the plurality of control pulses and prior to a subsequent informed pulse of the plurality of informed pulses; adjust, based on at least one respective ECAP, a second amplitude value that at least partially defines the plurality of control pulses of the electrical stimulation therapy; adjust a first amplitude value that at least partially defines the plurality of informed pulses to maintain a ratio of the second amplitude value to the first amplitude value, the adjusted first amplitude value being different than the adjusted second amplitude value); and control the stimulation generation circuitry to deliver the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (Claim 1: deliver, via the stimulation generation circuitry, the electrical stimulation therapy comprising at least the subsequent informed pulse of the plurality of informed pulses to the patient according to the adjusted first amplitude value and one or more subsequent control pulses of the plurality of control pulses according to the adjusted second amplitude value).
Regarding Claim 2, Claim 4 of the issued patent discloses the system of claim 1, wherein the stimulation generation circuitry is configured to deliver the plurality of primary stimulation pulses at a first frequency over a period of time, and wherein the first frequency is within a range from 50 Hz to 400 Hz (Claim 4: wherein the second frequency is within a range from 50 Hz to 400 Hz).
Regarding Claim 3, Claim 5 of the issued patent discloses the system of claim 2, wherein the first frequency is within a range from 50 Hz to 60 Hz (Claim 5: wherein the first frequency is within a range from 50 Hz to 60 Hz).
Regarding Claim 4, Claim 2 of the issued patent discloses the system of claim 2, wherein the stimulation generation circuitry is configured to deliver the plurality of secondary stimulation pulses at a second frequency over the period of time, and wherein the second frequency is greater than 400 Hz (Claim 2: greater than 400 Hz).
Regarding Claim 5, Claim 3 of the issued patent discloses the system of claim 4, wherein the second frequency is within a range from 900 Hz to 1200 Hz (Claim 3: 900-1200 Hz)
Regarding Claim 6, Claim 6 of the issued patent discloses the system of claim 1, wherein a second pulse width of the plurality of secondary stimulation pulses is less than a first pulse width of the plurality of primary stimulation pulses (Claim 6: wherein a pulse width of each informed pulse of the plurality of informed pulses is less than a pulse width of each control pulse of the plurality of control pulses).
Regarding Claim 11, Claim 1 of the issued patent discloses the system of claim 1, wherein the processing circuitry is configured to interleave the plurality of primary stimulation pulses with at least some of the plurality of secondary stimulation pulses (Claim 1: wherein the plurality of control pulses is interleaved with at least some informed pulses of the plurality of informed pulses).
Regarding Claim 13, Claim 14 of the issued patent discloses a method comprising: delivering a first primary stimulation pulse of a plurality of first primary stimulation pulses to a patient, the plurality of control stimulation pulses; delivering a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (Claim 14: A method comprising: delivering electrical stimulation therapy to a patient, the electrical stimulation therapy comprising a plurality of informed pulses at a first frequency over a period of time; delivering, over the period of time, a plurality of control pulses at a second frequency different than the first frequency, the plurality of control pulses being interleaved with at least some informed pulses of the plurality of informed pulses); sensing an evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse; identifying a characteristic of the ECAP signal; determining, based on the characteristic of the ECAP signal and a gain value, a second amplitude value that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses; determining a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (Claim 14: sensing, after one or more control pulses of the plurality of control pulses and prior to a subsequent informed pulse of the plurality of informed pulses, an evoked compound action potential (ECAP); adjusting, based on at least one respective ECAP, a second amplitude value that at least partially defines the plurality of control pulses of the electrical stimulation therapy; adjusting a first amplitude value that at least partially defines the plurality of informed pulses to maintain a ratio of the second amplitude value to the first amplitude value, the adjusted first amplitude value being different than the adjusted second amplitude value); and delivering the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (Claim 14: delivering the electrical stimulation therapy comprising at least the subsequent informed pulse of the plurality of informed pulses to the patient according to the adjusted first amplitude value and one or more subsequent control pulses of the plurality of control pulses according to the adjusted second amplitude value).
Regarding Claim 14, Claim 17 of the issued patent discloses the method of claim 13, further comprising delivering the plurality of primary stimulation pulses at a first frequency over a period of time, wherein the first frequency is within a range from 50 Hz to 400 Hz (Claim 17: 50-400 Hz).
Regarding Claim 15, Claim 18 of the issued patent discloses the method of claim 14, wherein the first frequency is within a range from 50 Hz to 60 Hz (Claim 18: 50-60 Hz).
Regarding Claim 16, Claim 15 of the issued patent discloses the method of claim 15, further comprising delivering the plurality of secondary stimulation pulses at a second frequency over the period of time, wherein the second frequency is greater than 400 Hertz (Hz) (Claim 16: greater than 400 Hz).
Regarding Claim 17, Claim 16 of the issued patent discloses the method of claim 16, wherein the second frequency is within a range from 900 Hz to 1200 Hz (Claim 16: 900-1200 Hz).
Regarding Claim 18, Claim 19 of the issued patent discloses the method of claim 13, wherein a second pulse width of the plurality of secondary stimulation pulses is less than a first pulse width of the plurality of primary stimulation pulses (Claim 18: wherein a pulse width of each informed pulse of the plurality of informed pulses is less than a pulse width of each control pulse of the plurality of control pulses).
Regarding Claim 20, Claim 20 of the issued patent discloses a non-transitory computer-readable storage medium comprising instructions that, when executed, causes one or more processors to: control delivery of a first primary stimulation pulse of a plurality of first primary stimulation pulses to a patient; control delivery of a first secondary stimulation pulse of a plurality of secondary stimulation pulses to the patient (Claim 20: A non-transitory computer-readable storage medium comprising instructions that, when executed, cause one or more processors to: control delivery of electrical stimulation therapy to a patient, the electrical stimulation therapy comprising a plurality of informed pulses at a first frequency over a period of time; control, over the period of time, delivery of a plurality of control pulses at a second frequency different than the first frequency, the plurality of control pulses being interleaved with at least some informed pulses of the plurality of informed pulses); sense an evoked compound action potential (ECAP) signal elicited by the first primary stimulation pulse; identify a characteristic of the ECAP signal; determine, based on the characteristic of the ECAP signal and a gain value, a second amplitude that at least partially defines a second primary stimulation pulse of the plurality of primary stimulation pulses; determine a second amplitude value that at least partially defines a second secondary stimulation pulse of the plurality of secondary pulses to maintain a first ratio of a first amplitude value of the first primary stimulation pulse to a first amplitude value of the first secondary stimulation pulse being equal to a second ratio of the second amplitude value of the second primary stimulation pulses to the second amplitude value of the second secondary stimulation pulses (Claim 20: receive, after one or more control pulses of the plurality of control pulses and prior to a subsequent informed pulse of the plurality of informed pulses, a sensed respective evoked compound action potential (ECAP); adjust, based on at least one respective ECAP, a second amplitude value that at least partially defines the plurality of control pulses of the electrical stimulation therapy; adjust a first amplitude value that at least partially defines the plurality of informed pulses to maintain a ratio of the second amplitude value to the first amplitude value, the adjusted first amplitude value being different than the adjusted second amplitude value); and control delivery of the second primary stimulation pulse according to the second amplitude value that at least partially defines the second primary stimulation pulse and the second secondary stimulation pulse according to the second amplitude value that at least partially defines the second secondary pulse (Claim 20: control delivery of the electrical stimulation therapy comprising at least the subsequent informed pulse of the plurality of informed pulses to the patient according to the adjusted first amplitude value and one or more subsequent control pulses of the plurality of control pulses according to the adjusted second amplitude value).
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12,133,982, in view of Torgerson.
Regarding Claim 19, Claim 14 of the issued patent discloses the method of claim 13, yet does not disclose further comprising interleaving the plurality of primary stimulation pulses with at least some secondary stimulation pulses of the plurality of secondary stimulation pulses such that at least one secondary stimulation pulse of the plurality of secondary stimulation pulses are delivered between consecutive primary stimulation pulses of the plurality of primary stimulation pulses. However, Torgerson teaches an analogous stimulation method, comprising interleaving the plurality of primary stimulation pulses with at least some secondary stimulation pulses of the plurality of secondary stimulation pulses such that at least one secondary stimulation pulse of the plurality of secondary stimulation pulses are delivered between consecutive primary stimulation pulses of the plurality of primary stimulation pulses (e.g. ¶¶ 6,7,32,44,55 Fig. 8-9: the two types of pulses are intermingled as this enables continuity in stimulation under different circumstances, e.g. posture change). Therefore, it would have been obvious to a person having ordinary skill in the art before to interleave the primary with the secondary pulses in a method according to the teachings of Claim 14 of the issued patent, as taught by Torgerson, in order to predictably titrate stimulation, and this would further enable continuity in stimulation without interruptions due to changes caused by position or posture changes, as suggested by Torgerson.
Allowable Subject Matter
Claims 7-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims, provided that a Terminal Disclaimer is approved and overcomes the relevant Double Patenting Rejections. Torgerson does not teach the limitations of Claims 7-10, and is furthermore focused on subthreshold stimulation and avoiding eCAPs, as opposed to the goal of recruitment.
Conclusion
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796