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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US 12,157,008. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application
Reference (US 12,157,008)
Claim 1. A method of delivering neurostimulation, the method comprising:
Claim 1. A method of delivering neurostimulation, the method comprising
delivering stimulation to a nerve of a patient using a first set of stimulation parameters;
delivering stimulation to a nerve of a patient using a first set of stimulation parameters
detecting a first heart rate change within a range between a baseline heart rate and a predefined threshold;
detecting a first heart rate response caused by the first set of stimulation parameters, the first heart rate response being within a neural fulcrum zone defined as a heart rate reduction between a baseline heart rate and a predefined threshold;
subsequent to detecting the first heart rate change, detecting a second heart rate change that is outside of the range between the baseline heart rate and the predefined threshold; and
subsequent to detecting the first heart rate response, detecting a second heart rate response caused by the first set of stimulation parameters, the second heart rate response being outside of the neural fulcrum zone;
delivering stimulation to the nerve of the patient using a second set of stimulation parameters based on the second heart rate change being outside of the range between the baseline heart rate and the predefined threshold.
delivering stimulation to the nerve of the patient using a second set of stimulation parameters based on the second heart rate response.
Claim 11. A neurostimulation system, comprising:
Claim 9. A neurostimulation system, comprising:
an electrode assembly; and
an electrode assembly; and
a neurostimulator coupled to the electrode assembly,
a neurostimulator coupled to the electrode assembly,
the neurostimulator comprising: a control circuit; and a memory operably coupled to the control circuit and comprising instructions that, when executed by the control circuit, cause the control circuit to:
the neurostimulator comprising: a control circuit; and
a memory operably coupled to the control circuit and comprising instructions that, when executed by the control circuit, cause the control circuit to:
deliver stimulation to a nerve of a patient using a first intensity;
deliver stimulation to a nerve of a patient using a first set of stimulation parameters;
detect a first heart rate change within a range between a baseline heart rate and a predefined threshold;
detect a first heart rate response caused by the first set of stimulation parameters, the first heart rate response being within a neural fulcrum zone defined as a heart rate reduction between a baseline heart rate and a predefined threshold;
subsequent to detecting the first heart rate change, detect a second heart rate change that is outside of the range between the baseline heart rate and the predefined threshold; and
subsequent to detecting the first heart rate response, detect a second heart rate response caused by the first set of stimulation parameters, the second heart rate response being outside of the neural fulcrum zone; and
deliver stimulation to the nerve of the patient using a second intensity based on the second heart rate change being outside of the range between the baseline heart rate and the predefined threshold.
deliver stimulation to the nerve of the patient using a second set of stimulation parameters based on the second heart rate response,
wherein, in response to the second heart rate response being a heart rate increase above the baseline heart rate, the second set of stimulation parameters has a higher intensity than the first set of stimulation parameters and,
in response to the second heart rate response being a heart rate reduction below the predefined threshold, the second set of stimulation parameters has a lower intensity than the first set of stimulation parameters.
Claim 15. A neurostimulator comprising:
Claim 15. A neurostimulator comprising:
a control circuit; and
a control circuit; and
a memory operably coupled to the control circuit and comprising instructions that, when executed by the control circuit, cause the control circuit to:
a memory operably coupled to the control circuit and comprising instructions that, when executed by the control circuit, cause the control circuit to:
deliver stimulation to a nerve of a patient using a first set of stimulation parameters;
deliver stimulation to a nerve of a patient using a first set of stimulation parameters;
detect a heart rate change outside of a range between a baseline heart rate and a predefined threshold; and
detect a first heart rate response caused by the first set of stimulation parameters, the first heart rate response being within a neural fulcrum zone defined as a heart rate reduction between a baseline heart rate and a predefined threshold;
deliver stimulation to the nerve of the patient using a second set of stimulation parameters based on the heart rate change.
subsequent to detecting the first heart rate response, detect a second heart rate response caused by the first set of stimulation parameters, the second heart rate response being outside of the neural fulcrum zone; and deliver stimulation to the nerve of the patient using a second set of stimulation parameters based on the second heart rate response.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 9-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Inagaki et al. (US 2008/0300642).
In re claim 1, Inagaki discloses a method of delivering neurostimulation [0051], the method comprising:
delivering stimulation to a nerve of a patient using a first set of stimulation parameters (fig. 3: S3; [0062]);
detecting a first heart rate change (S4B) within a range between a baseline heart rate (fig. 3: S3) and a predefined threshold (fig. 3: “YES” to block S4B occurs when heart rate from S4A changes at all but percentage change is greater than 5% i.e. a range which includes a predefined threshold of 5% of a percentage change);
subsequent to detecting the first heart rate change (fig. 3), detecting a second heart rate change (fig. 3: second heart rate change S20 occurs after first heart rate change S4B; [0070]: average heart rate is measured for a period of time and occurs after first heart rate change is detected) that is outside of the range between the baseline heart rate and the predefined threshold (fig. 3: S21 occurs when second heart rate change is outside threshold of more than 5% change i.e. outside range of 5% or less); and
delivering stimulation to the nerve of the patient using a second set of stimulation parameters based on the second heart rate change being outside of the range between the baseline heart rate and the predefined threshold (fig. 3: S21 occurs when second heart rate change is outside threshold of more than 5% change; [0016]: if reduction is less than 5%, then intensity of stimulation signal is increased).
In re claim 2, Inagaki discloses wherein the second set of stimulation parameters has a higher intensity than the first set of stimulation parameters ([0060]: intensity is increased if reduction rate is less than 5%).
In re claim 3, Inagaki discloses further comprising, in response to receiving a control input ([0016]: in response to receiving input that reduction of heart rate exceeds 20%), delivering stimulation to the nerve of the patient using a third set of stimulation parameters ([0016]: intensity is lowered when reduction of heart rate exceeds 20).
In re claim 4, Inagaki discloses wherein the third set of stimulation parameters is different than at least one of the first set of stimulation parameters or the second set of stimulation parameters ([0016]: third set of stimulation parameters would have a lower intensity than the intensity of the second set of stimulation parameters).
In re claim 5, Inagaki discloses wherein the control input comprises an input from at least one of a programmer ([0010]: control unit which controls intensity is interpreted as a programmer since it programs stimulation signal that will be delivered to stimulating electrodes; [0016]: programmer i.e. control unit would detect reduction rate of the heart rate and provide input that gets used to change the intensity) or a magnet.
In re claim 6, Inagaki discloses wherein the nerve is a vagus nerve of the patient [0059-0060].
In re claim 7, Inagaki discloses wherein the stimulation is delivered to the nerve of the patient [0052] via an implantable neurostimulation system (fig. 1: regeneration treatment apparatus 1 includes electrodes 2 and 3 which are implanted; [0052]).
In re claim 9, Inagaki discloses wherein detecting the second heart rate change occurs during a periodic monitoring of a heart rate of the patient ([0072-0073]: steps from Step S2 are repeated, which would include step S4A where heart rate is monitored i.e. a periodic monitoring of a heart rate occurs each time the steps from Step S2 are repeated; fig. 3-6: end of various processes return back to Step S2).
In re claim 10, Inagaki discloses wherein the predefined threshold is at least a 5% heart rate change from the baseline heart rate (S21).
In re claim 11, Inagaki discloses a neurostimulation system (1), comprising:
an electrode assembly (fig. 1: combination of 2 and 3; [0052]); and
a neurostimulator (fig. 2: 4; [0053]) coupled to the electrode assembly ([0053]: vagal stimulation output part 8 of control unit 4 outputs stimulation signal to stimulating electrodes 3),
the neurostimulator comprising:
a control circuit (7); and
a memory (10) operably coupled to the control circuit (fig. 2) and comprising instructions [0053, 0056].
Regarding the limitations, “…when executed by the control circuit, cause the control circuit to:
deliver stimulation to a nerve of a patient using a first intensity;
detect a first heart rate change within a range between a baseline heart rate and a predefined threshold;
subsequent to detecting the first heart rate change, detect a second heart rate change that is outside of the range between the baseline heart rate and the predefined threshold; and
deliver stimulation to the nerve of the patient using a second intensity based on the second heart rate change being outside of the range between the baseline heart rate and the predefined threshold”,
see in re claim 1 above.
In re claim 12, regarding the limitations, “wherein the instructions further cause the control circuit to, in response to receiving a control input, deliver stimulation to the nerve of the patient using a third intensity”, see in re claim 3 above.
In re claim 13, regarding the limitations, “wherein the third intensity is different than at least one of the first intensity or the second intensity”, see in re claim 4 above.
In re claim 14, regarding the limitations, “wherein the control input comprises an input from at least one of a programmer or a magnet”, see in re claim 5 above.
In re claim 15, regarding the limitations, “neurostimulator comprising:
a control circuit; and
a memory operably coupled to the control circuit and comprising instructions that, when executed by the control circuit, cause the control circuit to:
deliver stimulation to a nerve of a patient using a first set of stimulation parameters;
detect a heart rate change outside of a range between a baseline heart rate and a predefined threshold; and
deliver stimulation to the nerve of the patient using a second set of stimulation parameters based on the heart rate change”,
see in re claim 11 above.
In re claim 16, regarding the limitations, “wherein the second set of stimulation parameters has a higher intensity than the first set of stimulation parameters”, see in re claim 2 above.
In re claim 17, regarding the limitations, “wherein the instructions further cause the control circuit to, in response to receiving a control input, deliver stimulation to the nerve of the patient using a third set of stimulation parameters”, see in re claim 3 above.
In re claim 18, regarding the limitations, “wherein the third set of stimulation parameters is different than at least one of the first set of stimulation parameters or the second set of stimulation parameters”, see in re claim 4 above.
In re claim 19, regarding the limitations, “wherein the control input comprises an input from at least one of a programmer or a magnet”, see in re claim 5 above.
In re claim 20, regarding the limitations, “wherein detecting the heart rate change occurs during a continuous or periodic monitoring of a heart rate of the patient”, see in re claim 9 above, which discloses periodic monitoring.
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.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Inagaki et al. (US 2008/0300642) in view of Noren et al. (US 2010/0010555).
In re claim 8, Inagaki fails to explicitly disclose wherein detecting the second heart rate change occurs during a continuous monitoring of a heart rate of the patient.
Noren teaches an analogous implantable heart stimulation device [0001] for controlling an implantable heart stimulation [0001], and teaches wherein detecting a heart rate change ([028]: heart rate is monitored to detect changes) occurs during a continuous monitoring of a heart rate of the patient [0028].
Noren further teaches that the heart rate may need to be continuously monitored to determine changes of vagal stimulation pulses over time [0028].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method of delivering neurostimulation taught by Inagaki, to provide wherein detecting the second heart rate change occurs during a continuous monitoring of a heart rate of the patient, as taught by the heart rate change of Noren occurring during a continuous monitoring of a heart rate of a patient, because the heart rate may need to be continuously monitored to determine changes of vagal stimulation pulses over time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Maciejewski et al. (US 2010/0312299) discloses a system for vagal stimulation (abstract; [0069]) wherein an actual heart rate [0069] is compared with a target heart rate [0069] to adjust intensity of vagal stimulation [0069].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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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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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796 /DAVID HAMAOUI/SPE, Art Unit 3796
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