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 .
Status Of Claims
This action is in reply to the application filed on 06/06/2025.
Claims 1-20 are currently pending and have been examined.
Claim Rejections – 35 § 112(b)
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 10-20 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.
Claim 10, recites “tracking a number of single doses applied by the medical device”. It is unclear who or what is tracking a number of single doses applied by the medical device. It is also unclear how a number of single doses applied by the medical device is being tracked. Is a person writing down on a piece of paper each time a single dose is applied by the medical device? Claim 10 is therefore found to be indefinite, because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. All dependent claims, namely claims 11-20, are rejected for at least the same reason.
Claim 10, recites “causing the medical device to be switched from the activated mode to the deactivated mode after a specific number of single doses have been applied by the medical device”. It is unclear who or what is causing a medical device to be switched from the activated mode to the deactivated mode after a specific number of single doses have been applied by the medical device. Claim 10 is therefore found to be indefinite, because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. All dependent claims, namely claims 11-20, are rejected for at least the same reason.
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 obviousness-type 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 Omum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,354,741.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-20 of the instant pending application omit certain steps of claims 1-15 in the 12,354,741 patent. Therefore, claims 1-20 are prima facie obvious of claims 1-15 in the 12,354,741 patent, because it would have been obvious to omit certain steps with the motivation of providing system/method for providing a non-invasive neurostimulator that is deactivated after a specific number of doses have been emitted or a specific time period has elapsed.
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,854,695.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-20 of the instant pending application omit certain steps of claims 1-19 in the 11,854,695 patent. Therefore, claims 1-20 are prima facie obvious of claims 1-19 in the 11,854,695 patent, because it would have been obvious to omit certain steps with the motivation of providing system/method for providing a non-invasive neurostimulator that is deactivated after a specific number of doses have been emitted or a specific time period has elapsed.
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,581,090.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-20 of the instant pending application omit certain steps of claims 1-20 in the 11,581,090 patent. Therefore, claims 1-20 are prima facie obvious of claims 1-20 in the 11,581,090 patent, because it would have been obvious to omit certain steps with the motivation of providing system/method for providing a non-invasive neurostimulator that is deactivated after a specific number of doses have been emitted or a specific time period has elapsed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 of this title, if the differences between the claimed invention and the prior art axe 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 1-4, 7-12, 14-15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication US 2014/0324118 A1 to Simon et al. in view of U.S. Patent Application Publication US 2010/0179617 A1 to Fletcher et al.
Claim 1:
Simon discloses the following limitations as shown below:
A medical device comprising: a housing; a power supply coupled to the housing; a signal generator and one or more electrodes coupled to the housing, wherein the signal generator is configured to apply one or more electrical impulses to the one or more electrodes for a period of time, the period of time being defined as a single dose (see at least Paragraph 36, In a preferred embodiment of the invention, an electrical stimulator housing comprises a source of electrical power and two or more remote electrodes that are configured to stimulate the vagus nerve; Paragraph 37, The system may also comprise a docking station that is used to charge a rechargeable battery within the stimulator housing; Paragraph 252, device comprises an electrical impulse generator, a power source); and
wherein the device is configured to switch from an activated mode to a deactivated mode (see at least Paragraph 23, may enable the intended operational state. The intended operational state may be at least one of the states selected from the group consisting of initialization, receive therapeutic operation parameters, begin therapeutic operation, end therapeutic information, …; Paragraph 52, receive of a dose programming for medical device)
Simon may or may not specifically disclose the following limitations, but Fletcher as shown does:
after a specific number of single doses have been emitted by the signal generator (see at least Paragraph 13, deactivating the medical device when no approved therapies remain; Paragraph 18, the medical device is a neurostimulator; Paragraph 36, in the flowchart diagram shown in FIG. 2, the patient can be approved for a certain number of uses of the handheld controller to apply therapy. This is analogous to being prescribed and paying for an ingestible drug on a specific dose regimen. Uses of the handheld controller, and hence therapy, are managed by comparing patient therapy usage, activation of the … neurostimulator via the handheld controller, in the database with the number of approved uses for the patient. The approval can be any set of criteria or combinations thereof, for example but without limitation; clinical, like a physician's prescription, or; financial, like pre-paid uses or an automatic payment system from stored credit card information; Paragraph 50; Paragraph 57, prescription based approvals can take any number of forms, for example but without limitation, total number of uses, or time-dependent rate of uses like number of uses per day, per month or per year, or uses that expire in a defined amount of time).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of Simon with Fletcher with the motivation of limiting the use of the medical device for patient safety, because “… without some limitations mechanism, the medical device may become much like an over-the-counter pharmaceutical where usage is entirely up to the user” (Fletcher, see at least Paragraph 5).
Claim 10 recites substantially similar method limitations to those of apparatus claim 1 and, as such, are rejected for similar reasons as given above.
Claim 2:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon discloses the following limitations as shown below:
wherein the device is configured for coupling to software application comprising program instructions that, when executed by a processor, switches the device from the activated mode to the deactivated mode (see at least Paragraph 23, may enable the intended operational state. The intended operational state may be at least one of the states selected from the group consisting of initialization, receive therapeutic operation parameters, begin therapeutic operation, end therapeutic information, …; Paragraph 36, In a preferred embodiment of the invention, an electrical stimulator housing comprises a source of electrical power and two or more remote electrodes that are configured to stimulate the vagus nerve; Paragraph 37, The system may also comprise a docking station that is used to charge a rechargeable battery within the stimulator housing; Paragraph 52, receive of a dose programming for medical device; Paragraph 150, The stimulator may then be programmed to stimulate the vagus nerve in such a way as to amplify or enhance the inferred intentions of the individual, when biofeedback and automatic control are used simultaneously)
Simon may or may not specifically disclose the following limitations, but Fletcher as shown does:
after the specific number of single doses have been emitted by the signal generator (see at least Paragraph 13, deactivating the medical device when no approved therapies remain; Paragraph 18, the medical device is a neurostimulator; Paragraph 36, in the flowchart diagram shown in FIG. 2, the patient can be approved for a certain number of uses of the handheld controller to apply therapy. This is analogous to being prescribed and paying for an ingestible drug on a specific dose regimen. Uses of the handheld controller, and hence therapy, are managed by comparing patient therapy usage, activation of the … neurostimulator via the handheld controller, in the database with the number of approved uses for the patient. The approval can be any set of criteria or combinations thereof, for example but without limitation; clinical, like a physician's prescription, or; financial, like pre-paid uses or an automatic payment system from stored credit card information; Paragraph 50; Paragraph 57, prescription based approvals can take any number of forms, for example but without limitation, total number of uses, or time-dependent rate of uses like number of uses per day, per month or per year, or uses that expire in a defined amount of time)
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of Simon with Fletcher for at least the same reasons given for claim 1 above.
Claim 11 recites substantially similar method limitations to those of apparatus claim 2 and, as such, are rejected for similar reasons as given above.
Claim 3:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon may or may not disclose the following limitations but Fletcher as shown does:
wherein the specific number of single doses is about 2 to about 1000 (see at least Paragraph 13, deactivating the medical device when no approved therapies remain; Paragraph 18, the medical device is a neurostimulator; Paragraph 36, in the flowchart diagram shown in FIG. 2, the patient can be approved for a certain number of uses of the handheld controller to apply therapy. This is analogous to being prescribed and paying for an ingestible drug on a specific dose regimen. Uses of the handheld controller, and hence therapy, are managed by comparing patient therapy usage, activation of the … neurostimulator via the handheld controller, in the database with the number of approved uses for the patient. The approval can be any set of criteria or combinations thereof, for example but without limitation; clinical, like a physician's prescription, or; financial, like pre-paid uses or an automatic payment system from stored credit card information; Paragraph 50; Paragraph 57, prescription based approvals can take any number of forms, for example but without limitation, total number of uses, or time-dependent rate of uses like number of uses per day, per month or per year, or uses that expire in a defined amount of time).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of Simon with Fletcher for at least the same reasons given for claim 1.
Claim 14 recites substantially similar method limitations to those of apparatus claim 3 and, as such, are rejected for similar reasons as given above.
Claim 4:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon may or may not disclose the following limitations but Fletcher as shown does:
wherein the specific number of single doses is about 2 to about 100 (see at least Paragraph 13, deactivating the medical device when no approved therapies remain; Paragraph 18, the medical device is a neurostimulator; Paragraph 36, in the flowchart diagram shown in FIG. 2, the patient can be approved for a certain number of uses of the handheld controller to apply therapy. This is analogous to being prescribed and paying for an ingestible drug on a specific dose regimen. Uses of the handheld controller, and hence therapy, are managed by comparing patient therapy usage, activation of the … neurostimulator via the handheld controller, in the database with the number of approved uses for the patient. The approval can be any set of criteria or combinations thereof, for example but without limitation; clinical, like a physician's prescription, or; financial, like pre-paid uses or an automatic payment system from stored credit card information; Paragraph 50; Paragraph 57, prescription based approvals can take any number of forms, for example but without limitation, total number of uses, or time-dependent rate of uses like number of uses per day, per month or per year, or uses that expire in a defined amount of time).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of Simon with Fletcher for at least the same reasons given for claim 1.
Claim 15 recites substantially similar method limitations to those of apparatus claim 4 and, as such, are rejected for similar reasons as given above.
Claim 7:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon further discloses the following limitations:
wherein the medical device is a neurostimulator, wherein the signal generator transmits the one or more electrical impulses from the one or more electrodes transcutaneously and non-invasively through an outer skin surface of a patient such that the one or more electrical impulses modulates a nerve within the patient (see at least Abstract; Paragraph 2, electrical stimulation of the vagus nerve in a patient’s neck in order to treat various medical disorders; Paragraph 27, electrical impulses are applied through the electrodes of the stimulator to the vagus nerves; Paragraph 252, device comprises an electrical impulse generator, a power source).
Claim 18 recites substantially similar method limitations to those of apparatus claim 7 and, as such, are rejected for similar reasons as given above.
Claim 8:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon further discloses the following limitations:
wherein the one or more electrical impulses modulates a vagus nerve (see at least Abstract; Paragraph 2, electrical stimulation of the vagus nerve in a patient’s neck in order to treat various medical disorders; Paragraph 27, electrical impulses are applied through the electrodes of the stimulator to the vagus nerves; Paragraph 252, device comprises an electrical impulse generator, a power source).
Claim 19 recites substantially similar method limitations to those of apparatus claim 8 and, as such, are rejected for similar reasons as given above.
Claim 9:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon further discloses the following limitations:
wherein the signal generator and the power supply are housed within the housing (see at least Paragraph 36, In a preferred embodiment of the invention, an electrical stimulator housing comprises a source of electrical power and two or more remote electrodes that are configured to stimulate the vagus nerve; Paragraph 37, The system may also comprise a docking station that is used to charge a rechargeable battery within the stimulator housing; Paragraph 252, device comprises an electrical impulse generator, a power source).
Claim 12:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon further discloses the following limitations:
further comprising manipulating a user interface of a mobile device to control the processor (see at least Paragraph 107, the docking station 40 can communicate with the different types of devices, such as those illustrated in FIG. 5. Handheld devices may resemble conventional remote controls with a display screen (FIG. 5A) or mobile phones (FIG. 5B). Other type of devices with which the docking station may communicate are touchscreen devices (FIG. 5C) and laptop computers (FIG. 5D). As described below, such communication may also be performed wirelessly).
Claim 15:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon further discloses the following limitations:
further comprising transmitting the one or more electrical impulses from the one or more electrodes through the contact surface transcutaneously and non-invasively through an outer skin surface of a patient such that the one or more electrical impulses modulates a nerve within the patient (see at least Abstract; Paragraph 2, electrical stimulation of the vagus nerve in a patient’s neck in order to treat various medical disorders; Paragraph 27, electrical impulses are applied through the electrodes of the stimulator to the vagus nerves; Paragraph 252, device comprises an electrical impulse generator, a power source).
Claim 16:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon further discloses the following limitations:
wherein the one or more electrical impulses are sufficient to modulate a vagus nerve and causes the vagus nerve to generate an action potential to treat a medical condition within the patient (see at least Abstract; Paragraph 2, electrical stimulation of the vagus nerve in a patient’s neck in order to treat various medical disorders; Paragraph 27, electrical impulses are applied through the electrodes of the stimulator to the vagus nerves).
Claim 17:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon further discloses the following limitations:
further comprising coupling the housing to a software application and operating the software application to switch the device between the activated mode and the deactivated mode (see at least Paragraph 23, may enable the intended operational state. The intended operational state may be at least one of the states selected from the group consisting of initialization, receive therapeutic operation parameters, begin therapeutic operation, end therapeutic information, …; Paragraph 36, In a preferred embodiment of the invention, an electrical stimulator housing comprises a source of electrical power and two or more remote electrodes that are configured to stimulate the vagus nerve; Paragraph 37, The system may also comprise a docking station that is used to charge a rechargeable battery within the stimulator housing; Paragraph 52, receive of a dose programming for medical device; Paragraph 150, The stimulator may then be programmed to stimulate the vagus nerve in such a way as to amplify or enhance the inferred intentions of the individual, when biofeedback and automatic control are used simultaneously )
Claims 5-6 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication US 2014/0324118 A1 to Simon et al. in view of U.S. Patent Application Publication US 2010/0179617 A1 to Fletcher et al. and further in view of U.S. Patent Application Publication US 2014/0257438 A1 to Simon et al. (hereinafter referred to as Simon ‘438).
Claim 5:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above.
Simon may or may not disclose the following limitations but Simon ‘438 as shown does:
wherein the single dose has a time period of about thirty seconds to about 5 minutes (see at least Paragraph 72, A vagus nerve stimulation treatment according to the present invention is conducted for continuous period of thirty seconds to five minutes, preferably about 90 seconds to about three minutes and more preferably about two minutes (each defined as a single dose)).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of Simon and Fletcher with Simon ‘438 with the motivation “… to produce and apply the electrical impulses so as to interact with the signals of one or more nerves, in order to prevent or avert a stroke and/or transient ischemic attack, to ameliorate or limit the effects of an acute stroke or transient ischemic attack, and/or to rehabilitate a stroke patient” (Simon ‘438, Paragraph 57).
Claim 16 recites substantially similar method limitations to those of apparatus claim 5 and, as such, are rejected for similar reasons as given above.
Claim 6:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above.
Simon may or may not disclose the following limitations but Simon ‘438 as shown does:
wherein the single dose has a time period of about ninety seconds to about 3 minutes (see at least Paragraph 72, A vagus nerve stimulation treatment according to the present invention is conducted for continuous period of thirty seconds to five minutes, preferably about 90 seconds to about three minutes and more preferably about two minutes (each defined as a single dose)).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of Simon and Fletcher with Simon ‘438 for at least the same reasons given for claim 4.
Claim 17 recites substantially similar method limitations to those of apparatus claim 6 and, as such, are rejected for similar reasons as given above.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication US 2014/0324118 A1 to Simon et al. in view of U.S. Patent Application Publication US 2010/0179617 A1 to Fletcher et al. and further in view of U.S. Patent Application Publication US 2017/0182285 A1 to Tyler et al.
Claim 13:
The combination of Simon/Fletcher discloses the limitations as shown in the rejections above. Simon may or may not disclose the following limitations but Tyler as shown does:
further comprising downloading a software application onto the mobile device (see at least Paragraph 101, For example, the controller may be software, hardware, or firmware, and may include an application that can be downloaded by the user to run on a wireless-connectable (e.g., by Bluetooth) device (e.g., smartphone or tablet) to allow the user to select the waveforms delivered by the neurostimulator).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of Simon and Fletcher with Tyler with the motivation of enabling the convenience and advantage “… to provide apparatuses and methods for transdermal electrical stimulation for improving sleep that are both effective and comfortable for a user” (see at least Paragraph 23 of Tyler).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joy Chng whose telephone number is 571.270.7897. The examiner can normally be reached on Monday-Friday, 9:00am-5:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, JASON DUNHAM can be reached on 571.272.8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Joy Chng/
Primary Examiner, Art Unit 3686
Prosecution Insights