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 11/12/2024.
Claim 11 appears to be missing.
Claims 1-10 and 12-20 are currently pending and have been examined.
Claim Objections
Claim 11 appears to be missing. Appropriate correction is required.
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 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).
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).
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-l.jsp.
Claims 1-10 and 12-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,172,016.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-10 and 12-20 of the instant pending application omits certain steps of claims 1-17 in the 12,172,016 patent. Therefore, claims 1-10 and 12-20 are prima facie obvious of claims 1-17 because it would have been obvious to omit certain steps with the motivation of providing methods and systems to enable an initial provisioning and a refilling of a medical device, such as a non-invasive neurostimulator.
Claims 1-10 and 12-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,684,778.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-10 and 12-20 of the instant pending application omits certain steps of claims 1-24 in the 11,684,778 patent. Therefore, claims 1-10 and 12-20 are prima facie obvious of claims 1-24 because it would have been obvious to omit certain steps with the motivation of providing methods and systems to enable an initial provisioning and a refilling of a medical device, such as a non-invasive neurostimulator.
Claims 1-10 and 12-20 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 1-10 and 12-20 of the instant pending application omits certain steps of claims 1-20 in the 11,581,090 patent. Therefore, claims 1-10 and 12-20 are prima facie obvious of claims 1-20 because it would have been obvious to omit certain steps with the motivation of providing methods and systems to enable an initial provisioning and a refilling of a medical device, such as a non-invasive neurostimulator.
Statement regarding 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 and 12-20 are not rejected under 35 U.S.C. 101 because the claimed invention is not directed to an abstract idea.
Claim 1 recites a system comprising: a medical device comprising: a power supply, a signal generator and an electrode, wherein the signal generator is configured to apply one or more electrical impulses to the electrode for a period of time, the period of time being defined as a single dose; and a downloadable software application configured for coupling to the medical device, wherein the software application is configured to switch the medical device from an activated mode to a deactivated mode after a specific number of single doses have been applied by the signal generator. The claim recites physical, tangible system comprising a medical device comprising hardware components of a power supply, a signal generator and an electrode including downloadable software application configured for coupling to the medical device, and is therefore an apparatus.
Claim 15 recites a method comprising: generating an electrical impulse with an energy source coupled to a medical device; transmitting the one or more electrical impulses to a target nerve within a patient for a period of time defined as a single dose; and causing, via a downloadable software application, the medical device to switch from a deactivated to an activated mode for a specific number of single doses. The claim recites a method comprising generating an electrical impulse with an energy source coupled to a medical device; transmitting the one or more electrical impulses to a target nerve within a patient for a period of time defined as a single dose; and causing, via a downloadable software application, the medical device to switch from a deactivated to an activated mode for a specific number of single doses, and is therefore a process.
Claim 1-10 and 12-14: Step 2A Prong One
Claim 1 recites a system comprising: a medical device comprising: a power supply, a signal generator and an electrode, wherein the signal generator is configured to apply one or more electrical impulses to the electrode for a period of time, the period of time being defined as a single dose; and a downloadable software application configured for coupling to the medical device, wherein the software application is configured to switch the medical device from an activated mode to a deactivated mode after a specific number of single doses have been applied by the signal generator.
The claim does not recite any of the judicial exceptions enumerated in the 2019 PEG. For instance, the claim does not recite any mathematical relationships, formulas, or calculations. Further, the claim does not recite a mental process because the steps are not practically performed in the human mind. Finally, the claim does not recite any method of organizing human activity such as a fundamental economic concept or managing interactions between people. Thus, the claim is eligible because it does not recite a judicial exception. The reasoning applies to dependent claims 2-10 and 12-14.
Claim 15-20: Step 2A Prong One
Claim 15 recites a method comprising: generating an electrical impulse with an energy source coupled to a medical device; transmitting the one or more electrical impulses to a target nerve within a patient for a period of time defined as a single dose; and causing, via a downloadable software application, the medical device to switch from a deactivated to an activated mode for a specific number of single doses.
The claim does not recite any of the judicial exceptions enumerated in the 2019 PEG. For instance, the claim does not recite any mathematical relationships, formulas, or calculations. Further, the claim does not recite a mental process because the steps are not practically performed in the human mind. Finally, the claim does not recite any method of organizing human activity such as a fundamental economic concept or managing interactions between people. Thus, the claim is eligible because it does not recite a judicial exception. The reasoning applies to dependent claims 16-20.
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 1-10 and 12-20 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 1, recites in part, “wherein the signal generator is configured to apply one or more electrical impulses to the electrode for a period of time, the period of time being defined as a single dose”. It is unclear how the signal generator is configured to apply one or more electrical impulses to the electrode for a period of time, the period of time being defined as a single dose. Is there an algorithm or formula in a software or computer instructions that is being used to configure the signal generator to apply one or more electrical impulses to the electrode for a period of time, the period of time being defined as a single dose? Or is the signal generator configured in a particular physical manner to apply one or more electrical impulses to the electrode for a period of time, the period of time being defined as a single dose? Claim 1 is therefore found to be indefinite, because the resulting claims does not clearly set forth the metes and bounds of the patent protection desired. All dependent claims, namely claims 2-10 and 13-14 are rejected for at least the same reason.
Claim 2, recites in part, “wherein the software application is configured to interface with the storage medium based on the v switching the medical device from the activated mode to the deactivated mode such that the content of the storage medium is deleted or scrambled”. In this claim, “the v switching” lacks proper antecedent basis. For purposes of applying prior art, “the v switching” is interpreted as any v switching. Claim 2 is therefore found to be indefinite, because the resulting claims does not clearly set forth the metes and bounds of the patent protection desired.
Claim 15, recites in part, “generating an electrical impulse with an energy source coupled to a medical device”. It is unclear who or what is generating an electrical impulse with an energy source coupled to a medical device. Is there another device that is generating an electrical impulse with an energy source coupled to a medical device? Claim 15 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 16-20 are rejected for at least the same reason.
Claim 15, recites in part, “transmitting the one or more electrical impulses to a target nerve within a patient for a period of time defined as a single dose”. It is unclear who or what is transmitting the one or more electrical impulses to a target nerve within a patient for a period of time defined as a single dose. Claim 15 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 16-20 are rejected for at least the same reason.
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, 3, 4, 7, 9, 13, 14, 15, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication US 2015/0230760 A1 to Schneider in view U.S. Patent Application Publication US 2014/0324118 A1 to Simon et al and further in view of U.S. Patent Application Publication US 2012/0083700 A1 to Osorio.
Claim 1:
Schneider discloses the following limitations as shown below:
a medical device comprising: a power supply, a signal generator and an electrode, wherein the signal generator is configured to apply one or more electrical impulses to the electrode for a period of time, the period of time being defined as a single dose (see at least Paragraph 10; Paragraph 11, the medical device may include a display; a diagnostic component to provide diagnostic functionality; and a controller to regulate the operation of the diagnostic component and including processing logic; 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 28, medical device to be activated or reconfigured may output an optical code/symbol. An operator of the device may scan the optical code/symbol using a networked optical scanning device such as a smart phone, QRcode scanner, barcode scanner …; Paragraph 52, receive of a dose programming for medical device); and
instructions is configured to switching the medical device from an activated mode to a deactivated mode after a specific number of single doses have been applied by the signal generator (see at least Paragraph 8, medical device may be configured to receive the operation code and responsive to validation of the operation code may be configured to enable the intended operation state; Paragraph 9; Paragraph 10; Paragraph 11, to enable transition to a second state of the medical device; 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 28, medical device to be activated or reconfigured may output an optical code/symbol. An operator of the device may scan the optical code/symbol using a networked optical scanning device such as a smart phone, QRcode scanner, barcode scanner …; Paragraph 52, receive of a dose programming for medical device)
Schneider may or may not specifically disclose the following limitations, but Simon as shown does:
a medical device comprising: a power supply, a signal generator and an electrode, wherein the signal generator is configured to apply one or more electrical impulses to the electrode (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)
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 Schneider with Simon with the motivation that “… because treatment is powered and controlled from outside the body, changes to the treatment protocol can be made quickly and easily” (Simon, see at least Paragraph 268).
Schneider may or may not specifically disclose the following limitations, but Osorio as shown does:
a downloadable software application configured for coupling to the medical device, wherein the software application (see at least Paragraph 197, The monitoring unit 470 may download various parameters and program software into the medical device 400 for programming the operation of the medical device, and may also 5 receive and upload various status conditions and other data from the medical device 400)
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 Schneider and Simon with the feature of Osorio with the motivation of providing the benefit of being “… cost-effective (no hospital admission would be required as this invention's methods are implementable in small portable devices)” (Osorio, see at least Paragraph 91).
Claim 15 recites substantially similar method limitations to those of system claim 1 and, as such, is rejected for similar reasons as given above.
Claim 3:
The combination of Schneider/Simon/Osorio discloses the limitations as shown in the rejections above. Schneider further discloses the following limitations:
wherein the medical device comprises a housing and the processor is disposed within the housing (see at least Paragraph 34, According to some embodiments, medical device 104 may include at least one controller/computer/processing logic such as controller 110, which may be configured to operate/control the medical device for example: controlling therapeutic modes, ensuring safety, accessing memory, activating Wifi and controlling the ancillary circuits of medical device 104).
Claim 4:
The combination of Schneider/Simon/Osorio discloses the limitations as shown in the rejections above. Schneider further discloses the following limitations:
wherein the software application is configured for downloading onto a mobile device wirelessly coupled to the medical device (see at least Paragraph 28, According to embodiments, a medical device to be activated or reconfigured may output an optical code/symbol. An operator of the device may scan the optical code/symbol using a networked optical scanning device such as a smart phone, QRcode scanner, barcode scanner, camera, cellular phone, touch screen computer, handheld device and more and convey the scanned information to a management or authentication server over a wireless or wired data network).
Claim 7:
The combination of Schneider/Simon/Osorio discloses the limitations as shown in the rejections above. Schneider further discloses the following limitations:
wherein the storage medium is card shaped (see at least Paragraph 21, may be stored in a computer readable storage medium, such as, but is not limited to any type of disk … magnetic or optical cards, or any other type of media suitable for storing electronic instructions).
Claim 9:
The combination of Schneider/Simon/Osorio discloses the limitations as shown in the rejections above. Schneider further discloses the following limitations:
wherein the software application is configured to switch the medical device from an activated mode to a deactivated mode after a specific time period (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 56, may include information such as: … time dependent information and more. The operation code may only be valid for a given time (reads on “a defined time period”)).
Claim 17 recites substantially similar method limitations to those of system claim 9 and, as such, is rejected for similar reasons as given above.
Claim 13:
The combination of Schneider/Simon/Osorio discloses the limitations as shown in the rejections above. Schneider may or may not specifically disclose the following limitations, but Simon as shown does:
wherein the signal generator transmits the electrical impulse from the electrode transcutaneously and non-invasively through an outer skin surface of a patient such that the electrical impulse 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).
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 Schneider with Simon for the same reasons given for claim 1.
Claim 19 recites substantially similar method limitations to those of system claim 13 and, as such, is rejected for similar reasons as given above.
Claim 14:
The combination of Schneider/Simon/Osorio discloses the limitations as shown in the rejections above. Schneider may or may not specifically disclose the following limitations, but Simon as shown does:
wherein the electrical impulse modulates 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).
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 Schneider and Osorio with Simon for the same reasons given for claim 1.
Claim 20 recites substantially similar method limitations to those of system claim 14 and, as such, is rejected for similar reasons as given above.
Claims 2, 5, 6, 8, 10, 12, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication US 2015/0230760 A1 to Schneider in view U.S. Patent Application Publication US 2014/0324118 A1 to Simon et al. in view of U.S. Patent Application Publication US 2012/0083700 A1 to Osorio and further in view U.S. Patent Application Publication US 2015/0339460 A1 to Marsico.
Claim 2:
The combination of Schneider/Simon/Osorio discloses the limitations as shown in the rejections above. Schneider discloses the limitations as shown in the rejections above. Schneider may or may not specifically disclose the following limitations, but Marsico as shown does:
further comprising a storage medium that includes a content, wherein the software application is configured to interface with the storage medium based on the v switching the medical device from the activated mode to the deactivated mode such that the content of the storage medium is deleted or scrambled (see at least Paragraph 40, Once each patient scans the QR code and their user identifier is provided to the hosting scan-triggered application server (along with the healthcare instruction set identifier and their reference date/time information), a healthcare provider can access the patient's copy of the instruction set and edit, delete, add or otherwise adjust any of the instruction steps for that patient. Such access may, for example, be provided to a physician via a provisioning interface that may be accessed via the healthcare provider's computer or mobile device).
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 Schneider, Simon and Osorio with Marsico with the motivation to “ … enable a scanning user to quickly and easily access healthcare instruction step information, receive instruction step reminders, signal compliance with these instruction steps, and receive associated instruction step compliance incentives” (Marsico, see at least Paragraph 3).
Claim 16 recites substantially similar method limitations to those of system claim 2 and, as such, is rejected for similar reasons as given above.
Claim 5:
The combination of Schneider/Simon/Osorio/Marsico discloses the limitations as shown in the rejections above. Schneider further discloses the following limitations:
wherein the content includes a defined time period for the activated 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 56, may include information such as: … time dependent information and more. The operation code may only be valid for a given time (reads on “a defined time period”)).
Claim 6:
The combination of Schneider/Simon/Osorio/Marsico discloses the limitations as shown in the rejections above. Schneider further discloses the following limitations:
wherein the content includes a defined number of doses for the activated 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).
Claim 8:
The combination of Schneider/Simon/Osorio/Marsico discloses the limitations as shown in the rejections above. Schneider further discloses the following limitations:
further comprising a reader configured to read the content from the storage medium (see at least Paragraph 28, According to embodiments, a medical device to be activated or reconfigured may output an optical code/symbol. An operator of the device may scan the optical code/symbol using a networked optical scanning device such as a smart phone, QRcode scanner, barcode scanner, camera, cellular phone, touch screen computer, handheld device and more and convey the scanned information to a management or authentication server over a wireless or wired data network).
Claim 10:
The combination of Schneider/Simon/Osorio/Marsico discloses the limitations as shown in the rejections above. Schneider may or may not specifically disclose the following limitations, but Marsico as shown does:
wherein the content includes a first content and a second content, wherein the reader is configured to read the first content from the storage medium such that the software application erases or scrambles the first content and does not erase or scramble the second content (see at least Paragraph 40, Once each patient scans the QR code and their user identifier is provided to the hosting scan-triggered application server (along with the healthcare instruction set identifier and their reference date/time information), a healthcare provider can access the patient's copy of the instruction set and edit, delete, add or otherwise adjust any of the instruction steps for that patient. Such access may, for example, be provided to a physician via a provisioning interface that may be accessed via the healthcare provider's computer or mobile device).
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 Schneider, Simon and Osorio with Marsico for the same reasons given for claim 2.
Claim 18 recites substantially similar method limitations to those of system claim 10 and, as such, is rejected for similar reasons as given above.
Claim 12:
The combination of Schneider/Simon/Osorio/Marsico discloses the limitations as shown in the rejections above. Schneider further discloses the following limitations:
wherein the first content includes a single dose (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).
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