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 .
Priority
This application is claiming the benefit of prior-filed application No. 15/372970 under 35 U.S.C. 120, 121, 365(c), or 386(c). Copendency between the current application and the prior application is required. Since the applications are not copending, the benefit claim to the prior-filed application is improper. Applicant is required to delete the claim to the benefit of the prior-filed application, unless applicant can establish copendency between the applications.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,700,145. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which is similar to the claims of U.S. Patent No. 8,700,145 which is also a method to treating stroke patient’s motor deficits by providing vagus nerve stimulation so that it is timed with the task such that the stimulation pulse trains begin after the beginning of the respective selected therapeutic tasks and end prior to the end of the respective selected therapeutic tasks (i.e. the stimulation is provided during the performance of the motor therapy by the patient).
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 9089707. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which are similar to the claims of U.S. Patent No. 9089707 which are also directed to treating stroke patient’s motor deficits by providing a repeated paired training therapy and providing vagus nerve stimulation so that it is timed with the task and wherein the vagus nerve stimulation pulse train is not presented between performances of the selected therapeutic task (i.e. the stimulation is provided during the performance of the motor therapy by the patient). . Further the dependent claims of the current application are similar to the dependent claims of U.S. Patent No. 9089707.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9522273. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which are similar to the method claims of U.S. Patent No. 9522273 which are also directed to treating a stroke patient’s motor deficits by selecting therapeutic tasks and providing vagus nerve stimulation paired with therapeutic task so that there is no stimulation between movement execution and thus improve the patient's motor deficits and wherein the vagus nerve stimulation pulse train is not presented between performances of the selected therapeutic task (i.e. the stimulation is provided during the performance of the motor therapy by the patient). Further the dependent claims of the current application are similar to the dependent claims of U.S. Patent No. 9522273.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9474904. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which are similar to the claims of copending U.S. Patent No. 9474904 which are also directed to treating stroke patient’s motor deficits by selecting therapeutic tasks, detecting motion during the repetitive performances of the task and providing vagus nerve stimulation so that it is timed with the task ( i.e. provided while the patient is performing a movement of the therapeutic task) such that the vagus nerve stimulation pulse train is not presented between performances of the selected therapeutic task (i.e. the stimulation is provided during the performance of the motor therapy by the patient). Further the dependent claims of the current application are similar to the dependent claims of U.S. Patent No. 9474904.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9504831. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which are similar to the claims of U.S. Patent No. 9504831 which are also directed to treating stroke patient’s motor deficits by providing a vagus nerve stimulation so that it is timed with a patient performing a task and wherein the vagus nerve stimulation pulse train is not presented between performances of the selected therapeutic task and terminating the stimulation of the vagus nerve so that there is no stimulation between movement execution (i.e. the stimulation is provided during the performance of the motor therapy by the patient). Further the dependent claims of the current application are similar to the dependent claims of U.S. Patent No. 9504831.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 9522274. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which are similar to the claims of U.S. Patent No. 9522274 which are also directed to treating motor deficits by exposing a patient to a plurality of therapeutic motions and applying vagus nerve stimulation pulse trains in temporal proximity (i.e. the stimulation is provided during the performance of the motor therapy by the patient) to the respective task to improve the patient’s motor deficits. Further the dependent claims of the current application are similar to the dependent claims of U.S. Patent No. 9522274.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9533152. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which are similar to the claims of U.S. Patent No. 9533152 which are also directed to treating motor deficits by directing a patient to execute a plurality of therapeutic motions and applying vagus nerve stimulation pulse trains in temporal proximity ( i.e. timed with the task, the stimulation is provided during the performance of the motor therapy by the patient) to the respective task to improve the patient’s motor deficits. ). Further the dependent claims of the current application are similar to the dependent claims of U.S. Patent No. 9533152.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 95222272. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which are similar to the claims of U.S. Patent No. 95222272 which are also directed to treating stroke patient’s motor deficits by providing a vagus nerve stimulation so that it is provided while the patient is performing the task and terminating the stimulation of the vagus nerve so that there is no stimulation between movement execution (i.e. the stimulation is provided during the performance of the motor therapy by the patient). Further the dependent claims of the current application are similar to the dependent claims of U.S. Patent No. 9522272.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49 of U.S. Patent No. 11638824. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which is similar to the claims of U.S. Patent No. 11638824 which are also directed to a motor-deficit-therapeutic method for treatment of a patient who has stroke-induced hemiparesis, the method comprising: providing, to the patient afflicted with a stroke-induced hemiparesis, a neurostimulator configured to stimulate a vagus nerve of the patient using electrical, magnetic, acoustic or mechanical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs at least during performance by the patient of a motor therapy session which is stroke-induced hemiparesis-therapeutic, thereby improving the patient's stroke-induced hemiparesis. Further the dependent claims of the current application are similar to the dependent claims of U.S. Patent No. 11638824.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11116933. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which is similar to the claims of U.S. Patent No. 11116933 which are also directed to a method of treating a stroke motor deficit in a patient comprising: providing a neurostimulator to the patient to stimulate a vagus nerve of the patient electrically; detecting a preliminary event that anticipates a pairing event included in a motor therapy; initiating, based on detection of the preliminary event, stimulation of the patient's vagus nerve with the neurostimulator before a beginning of the pairing event; continuously applying the stimulation of the patient's vagus nerve with the neurostimulator so that the stimulation overlaps an initial interval in a duration of the pairing event; and thereby reducing the patient's stroke motor deficit. Further dependent claims 2-17,19-34, 36-51 and 53-68 are similar to the dependent claims of U.S. Patent No. 11116933.
Claims 1, 18, 35 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-68 of U.S. Patent No. 12151104. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are directed to methods of treating hemiparesis in a patient comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator to stimulate the patient’s vagus nerve using electrical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator which is similar to the claims of U.S. Patent No. 12151104 which are also directed to a motor-deficit-therapeutic method for treatment of a patient who has hemiparesis, the method comprising: providing, to the patient afflicted with a hemiparesis, a neurostimulator configured to stimulate a vagus nerve of the patient using electrical, magnetic, optical, acoustic or mechanical stimulation; and initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs at least during performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis.to a method of treating a stroke motor deficit in a patient comprising: providing a neurostimulator to the patient to stimulate a vagus nerve of the patient electrically; detecting a preliminary event that anticipates a pairing event included in a motor therapy; initiating, based on detection of the preliminary event, stimulation of the patient's vagus nerve with the neurostimulator before a beginning of the pairing event; continuously applying the stimulation of the patient's vagus nerve with the neurostimulator so that the stimulation overlaps an initial interval in a duration of the pairing event; and thereby reducing the patient's stroke motor deficit. Further dependent claims 2-17,19-34, 36-51 and 53-68 are similar to the dependent claims of U.S. Patent No. 12151104.
Firlik et al (U.S. Patent Application Publication Number: US 2007/0179534, hereinafter “Firlik” - APPLICANT CITED) teach a system and method for providing a variety of patient interactive rehabilitation exercises in conjunction with neural stimulation to treat neurological disorders that includes hemiparesis and while they do mention vagal stimulation for neurological disorders (e.g. abstract, [0030], [0037], [0070]) they fail to teach specifically electrical stimulation of the vagus nerve to a patient afflicted with hemiparesis in combination with the recited steps of the claimed invention.
While no prior art rejection is provided for the claims, they are not indicated as allowable due to the double patenting rejections discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/ Primary Examiner, Art Unit 3792
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