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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/10/2024, 03/24/2025, 07/23/2025, 10/17/2025, and 02/09/2026 are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 111, 113, 115, 117, and 121. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 14 is objected to because of the following informalities: Claim 14 line 3 reads "the user interface" should read "a user interface". Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 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.
Claims 2, 13 and 14 states “confirming that the external programmer is paired with the implantable microstimulator before transmitting the user input”. It is unclear whether the confirming is performed by the external programmer, the implantable microstimulator, or another component and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification fails to disclose how the confirmation is performed or what criteria is used to determine that the external programmer is paired with the implantable microstimulator.
See MPEP 2181(II)(B) and 2173.05(g) discloses notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)).
Dependent claims 3-12, 15-22 inherit the same deficiencies.
Claim 10 recites the limitation "user interface" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Applicant is advised that should claim 10 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12-21, and 23 of U.S. Patent No. 12121726 B2 and Huston et al. (US 20060178703 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 2-22 under examination are anticipated by claims 1-10, 12-21, and 23 of the reference patent. Every limitation in the application under examination claims is recited in the conflicting reference patent claims, and the differences between the claims are highlighted below by bolding all limitations that differ, italicizing additional limitations, and underlying limitations that will be addressed below.
Instant Application
U.S. Patent 12121726 B2
2. A system for treating rheumatoid arthritis, the system comprising: an implantable microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP); an external programmer configured to communicate with the implantable microstimulator; and a non-transitory computer-readable medium including computer-program instructions, that, when executed by one or more processors, perform a computer-implemented method comprising: receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator to treat rheumatoid arthritis; confirming that the external programmer is paired with the implantable microstimulator before transmitting the user input; and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
1. A system for treating inflammation, the system comprising: an implantable microstimulator configured to apply neural stimulation to a cholinergic anti- inflammatory pathway (NCAP); an external programmer configured to communicate with the implantable microstimulator; and a non-transitory computer-readable medium including computer-program instructions, that, when executed by one or more processors, perform a computer-implemented method comprising: presenting a user interface for adjusting stimulation parameters of the implantable microstimulator; receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator; confirming that the external programmer is paired with the implantable microstimulator before transmitting the user input; and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
3. The system of claim 2, wherein the implantable microstimulator is a leadless implantable microstimulator.
2. The system of claim 1, wherein the implantable microstimulator is a leadless implantable microstimulator.
4. The system of claim 2, wherein the non-transitory computer-readable medium is configured to execute on a user's mobile device.
3. The system of claim 1, wherein the non-transitory computer-readable medium is configured to execute on a user's mobile device.
5. The system of claim 2, wherein the external programmer comprises a charger.
4. The system of claim 1, wherein the external programmer comprises a charger.
6. The system of claim 2, wherein the computer-implemented method further comprises receiving data associated with a patient metric and adjusting the dosing based on the patient metric.
5. The system of claim 1, wherein the computer-implemented method further comprises receiving data associated with a patient metric and adjusting the dosing based on the patient metric.
7. The system of claim 6, wherein the patient metric comprises a biomarker for inflammation.
6. The system of claim 5, wherein the patient metric comprises a biomarker for inflammation.
8. The system of claim 7, wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
7. The system of claim 6, wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
9. The system of claim 6, wherein the patient metric comprises an activity metric or a physiological metric.
8. The system of claim 5, wherein the patient metric comprises an activity metric or a physiological metric.
10. The system of claim 2, further comprising receiving, from the user interface, an emergency stop command and transmitting the emergency stop directly to the implantable microstimulator.
9. The system of claim 1, further comprising receiving, from the user interface, an emergency stop command and transmitting the emergency stop directly to the implantable microstimulator.
11. The system of claim 2, wherein receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator comprises receiving the user input when the external programmer is not in communication with the implantable microstimulator.
10. The system of claim 1, wherein receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator comprises receiving the user input when the external programmer is not in communication with the implantable microstimulator.
12. The system of claim 2, wherein the external programmer is configured to prevent improper modification of dosing.
12. The system of claim 1, wherein the external programmer is configured to prevent improper modification of dosing.
13. A system for treating rheumatoid arthritis, the system comprising: an implantable microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP);an external programmer configured to communicate with the implantable microstimulator; and a non-transitory computer-readable medium including computer-program instructions, that, when executed by one or more processors, perform a computer-implemented method comprising: receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator to treat rheumatoid arthritis; confirming that the external programmer is paired with the implantable microstimulator; transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator; and receiving an emergency stop and directly transmitting the emergency stop to the implantable microstimulator.
13. A system for treating inflammation, the system comprising: an implantable microstimulator configured to apply neural stimulation to a cholinergic anti- inflammatory pathway (NCAP); an external programmer configured to communicate with the implantable microstimulator; and a non-transitory computer-readable medium including computer-program instructions, that, when executed by one or more processors, perform a computer-implemented method comprising: presenting a user interface for adjusting stimulation parameters of the implantable microstimulator; receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator; confirming that the external programmer is paired with the implantable microstimulator; transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator; and receiving an emergency stop and directly transmitting the emergency stop to the implantable microstimulator.
14. A method of treating rheumatoid arthritis using an implantable microstimulator, the method comprising: receiving, through the user interface on a user's mobile device, user input for delaying dosing by the implantable microstimulator or adjusting stimulation parameters of the implantable microstimulator for dosing delivered by the implantable microstimulator to treat rheumatoid arthritis, wherein the user input for delaying dosing is received when an external programmer is not in communication with the implantable microstimulator; confirming that the external programmer is paired with the implantable microstimulator; transmitting the user input from the user's mobile device indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator; and adjusting the implantable microstimulator based on the user input.
14. A method of treating inflammation using an implantable microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP), an external programmer configured to communicate with the implantable microstimulator, and a user's mobile device, the method comprising: presenting a user interface for adjusting stimulation parameters of the implantable microstimulator on the user's mobile device; receiving, through the user interface, user input for delaying dosing by the implantable microstimulator or adjusting stimulation parameters of the implantable microstimulator for dosing delivered by the implantable microstimulator, wherein the user input for delaying dosing is received when the external programmer is not in communication with the implantable microstimulator; confirming that the external programmer is paired with the implantable microstimulator; transmitting the user input from the user's mobile device indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator; and adjusting the implantable microstimulator based on the user input
15. The method of claim 14, wherein the implantable microstimulator is a leadless implantable microstimulator.
15. The method of claim 14, wherein the implantable microstimulator is a leadless implantable microstimulator.
16. The method of claim 14, wherein the external programmer comprises an inductive charger.
16. The method of claim 14, wherein the external programmer comprises an inductive charger.
17. The method of claim 14, further comprising receiving data associated with a patient metric and adjusting the dosing based on the patient metric.
17. The method of claim 14, further comprising receiving data associated with a patient metric and adjusting the dosing based on the patient metric.
18. The method of claim 17, wherein the patient metric comprises a biomarker for inflammation
18. The method of claim 17, wherein the patient metric comprises a biomarker for inflammation.
19. The method of claim 17, wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
19. The method of claim 18, wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
20. The method of claim 17, wherein the patient metric comprises an activity metric or a physiological metric.
20. The method of claim 17, wherein the patient metric comprises an activity metric or a physiological metric.
21. The method of claim 14, further comprising receiving an emergency stop and transmitting the emergency stop directly to the implantable microstimulator.
21. The method of claim 14, further comprising receiving an emergency stop and transmitting the emergency stop directly to the implantable microstimulator.
22. The method of claim 14, further comprising preventing, by the external programmer, improper modification of dosing
23. The method of claim 14, further comprising preventing, by the external programmer, improper modification of dosing.
As shown in the mapping above, claims 2 and 13-14 of the instant application differs from claims 1 and 13-14 of the reference patent respectively, in that it recites “treating inflammation” rather than “treating rheumatoid arthritis.” However, the instant disclosure at paragraph [0130] shows that “rheumatoid arthritis” falls within the broadest reasonable interpretation of treating diseases caused by “inflammation.” Thus, “treating inflammation” of the reference patent claims 1 and 13-14 anticipates “treating rheumatoid arthritis” of claims 2 and 13-14 of the instant application.
Huston et al. teaches treating rheumatoid arthritis (para. 0066 (condition can be mediated by a localized inflammatory cytokine cascade, as in rheumatoid arthritis)). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to treat rheumatoid arthritis, as disclosed in Huston, within the system of claims 1 and 13, and the method of claim 14, to enable treatment of rheumatoid arthritis by applying neural stimulation to modulate the inflammatory response associated with the disease. Doing so would reduce levels of pro-inflammatory cytokines and expand the therapeutic applicability of Skelton’s system and method.
Claims 2-10, 12, 15-21, and 23 of the instant application include all the limitations of claims 3-12 and 15-22 of the instant application.
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-7, 9-13-18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Skelton et al. (US 20100280500 A1), hereinafter Skelton, and in view of Huston et al. (US 20060178703 A1), hereinafter Huston, and in further view of Whitehurst et al. (US 20110077721 A1), hereinafter Whitehurst, and Moffitt et al. (US 20160082261 A1), hereinafter Moffitt, and Wetmore et al., (US 20160008632 A1), hereinafter Wetmore.
Regarding claim 2, Skelton teaches a system (para. 0032 (implantable electrical stimulation system)) the system comprising:
an implantable microstimulator (para. 0004 (implantable stimulator device)) configured to apply neural stimulation (para. 0003 (neurostimulator), 0046 (IMD may be used with… peripheral nerve stimulation));
an external programmer (Fig. 6, element 20) configured to communicate with the implantable microstimulator (para. 0064 (IMD communicates with external programmer)); and
a non-transitory computer-readable medium including computer-program instructions (para. 0009 (computer readable storage medium comprising instructions)), that, when executed by one or more processors (para. 0093 (memory may store instructions for execution by processor)), perform a computer-implemented method (para. 0239 (instructions may be executed)) comprising:
receiving user input (para. 0129 (receive input from a user)) for adjusting or delaying dosing delivered by the implantable microstimulator (para. 0231 (receive input from a user defining a new time period, receive a selection of new therapy parameters));
external programmer is paired with the implantable microstimulator before transmitting the user input (para. 0125 (external programmer includes telemetry circuit), 0130 (telemetry circuit may communicate with IMD… when the telemetry circuit detects the proximity of stimulator… telemetry circuit may communicate with IMD when signaled by a user through user interface));
Skelton does not explicitly disclose a system treating rheumatoid arthritis, a microstimulator, applying neural stimulation to a NCAP, confirming that the external programmer is paired with the implantable microstimulator, and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Huston teaches treating rheumatoid arthritis (abstract (A method and an apparatus for treating a patient suffering from, or at risk for, a condition mediated by the inflammatory cytokine cascade, by electrically stimulating vagus nerve activity in an amount sufficient to inhibit the inflammatory cytokine cascade), para. 0067 (conditions which can be usefully treated include… rheumatoid arthritis)) and apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP) (0010 (electrical vagus nerve stimulation was sufficient for activation of the cholinergic anti-inflammatory pathway), 0085 (cholinergic anti-inflammatory pathway activation is responsive to… electrical stimulation parameters)).
Huston does not teach an implantable microstimulator, confirming that the external programmer is paired with the implantable microstimulator, and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Whitehurst teaches a system (para. 0001 (system)), the system comprising:
an implantable microstimulator (para. 001 (implantable microstimulator)) configured to apply stimulation (para. 0065 (stimulation)).
Whitehurst does not teach confirming that the external programmer is paired with the implantable microstimulator and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Wetmore teaches confirming that the external programmer is paired with the implantable microstimulator (para. 0159 (A user indicates her request to pair a neuromodulation puck with the Bluetooth device… to confirm which puck is to be paired… to confirm successful pairing, the neuromodulation puck can be configured to generate a sound)), 0015 (puck – neuromodulation apparatus)).
Wetmore does not teach transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Moffitt teaches transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator (para. 0072 (programming device is configured to be communicatively coupled to modulation device), 0080 (implantable modulation device (implantable pulse generator)), 0078 (GUI includes… any type of user input that allow the user to program the modulation parameters… programming device may transmit the plurality of modulation parameters to the modulation device)).
Skelton, Huston, Whitehurst, Moffitt, and Wetmore are all considered to be analogous to the claimed invention because they are in the same field of applying neural stimulation to a user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s system to incorporate the teachings of Huston and provide a system for treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway. Skeleton teaches a system to treat chronic pain but does not disclose treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway (para. 0039). Huston teaches that applying stimulation to the NCAP, reduces cytokine production (para. 0085). One of ordinary skill in the art would have been motivated to target the NCAP as Huston teaches that the NCAP’s effects are long lasting after stimulation (para. 0087). Therefore, such targeting would improve treatment specificity, providing a more effective therapeutic approach for managing rheumatoid arthritis.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst and provide a microstimulator. Skelton teaches an implantable stimulator device, but does not explicitly disclose a microstimulator. Therefore, incorporating the microstimulator taught by Whitehurst, would allow a minimal surgical procedure by implanting the microstimulator via a small incision, preventing more complicated surgical procedures, thereby reducing tissue trauma.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Wetmore and provide a way to confirm pairing of the external programmer with the microstimulator. Doing so would ensure a connection between the two components before any important user information is transmitted.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s user input to incorporate the teachings of Moffitt and provide a transmission of the user input to the implantable microstimulator through the external programmer. Doing so would allow the user inputs received by the external programmer to be communicated to the microstimulator, enabling an improved system of reliability without requiring the direct interaction with the microstimulator.
Regarding claim 3, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 2.
Skelton teaches wherein the implantable microstimulator is a leadless implantable microstimulator (para. 0043 (IMD may be a leadless stimulator).
Regarding claim 4, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 2, wherein the non-transitory computer-readable medium is configured to execute on a user's mobile device (para. 0125 (programmer may be a cell phone)).
Regarding claim 5, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 2, wherein the external programmer comprises a charger (para. 0131 (external programmer may include a charger module capable of recharging a power source)).
Regarding claim 6, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 2, wherein the computer-implemented method further comprises receiving data associated with a patient metric and adjusting the dosing based on the patient metric (para. 0003 (allow for therapy activation, and/or adjustments to therapy parameters), 0058 (may transmit parameter adjustments to support therapy modification relating to changes in the posture state of patient), 0110 (processor may also adjust therapy for a new posture when posture state module indicates that patient has in fact changes postures… stimulation adjustments in response to posture state may be automatic or semi-automatic), 0226 (IMD receives a therapy adjustment from a programmer to define new therapy parameters)).
Regarding claim 7, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 6.
Skeleton does not teach wherein the patient metric comprises a biomarker for inflammation.
Huston teaches wherein the patient metric comprises a biomarker for inflammation (Fig. 4, Fig. 5, para. 0051 (proinflammatory cytokine is TNF), 0083 (TNF concentrations)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Huston and provide a biomarker for inflammation. Doing so provides a relevant indicator of inflammatory status as pro-inflammatory cytokines are associated with rheumatoid arthritis. Therefore, tracking cytokine levels may allow determination of whether the neural stimulation is effectively suppressing inflammatory signaling.
Regarding claim 9, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 6, wherein the patient metric comprises an activity metric or a physiological metric (para. 0115 (posture state module may sensor physiological parameters of patient, may include heart rate, respiration rate)), 0109 (posture state module… may correspond to an activity and/or posture undertaken by patient)).
Regarding claim 10, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 2, further comprising receiving, from the user interface, an emergency stop command and transmitting the emergency stop directly to the implantable microstimulator (para. 0128 (user interface in order to … turn stimulation off)).
Regarding claim 11, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 2, wherein receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator comprises receiving the user input when the external programmer is not in communication with the implantable microstimulator (para. 0121 (telemetry circuit [within the IMD] may send information to and receive information from external programmer on a continuous basis… or upon request from the stimulator or programmer)).
Regarding claim 12, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the system of claim 2.
Skelton teaches the external programmer (Fig. 6, element 20).
Skelton does not teach the external programmer preventing improper modification of dosing.
Moffitt teaches wherein the external programmer is configured to prevent improper modification of dosing (para. 0078 (programming control circuit may check values of the plurality of modulation parameters against safety rules to limit these values within constraints of the safety rules), 0072 (delivery of the neuromodulation is controlled by using a plurality of modulation parameters)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s external programmer to incorporate the teachings of Moffitt to prevent improper modification of dosing. Doing so would provide a safety check to ensure that the patient is modifying the doses within the parameters of the stimulation therapy.
Regarding claim 13, Skelton teaches a system (para. 0032 (implantable electrical stimulation system)), the system comprising:
an implantable microstimulator (para. 0004 (implantable stimulator device)) configured to apply neural stimulation (para. 0003 (neurostimulator));
an external programmer (Fig. 6, element 20) configured to communicate with the implantable microstimulator (para. 0064 (IMD communicates with external programmer)); and
a non-transitory computer-readable medium including computer-program instructions (para. 0009 (computer readable storage medium comprising instructions)), that, when executed by one or more processors (para. 0093 (memory may store instructions for execution by processor)), perform a computer-implemented method (para. 0239 (instructions may be executed)) comprising:
receiving user input (para. 0129 (receive input from a user)) for adjusting or delaying dosing delivered by the implantable microstimulator (para. 0231 (receive input from a user defining a new time period, receive a selection of new therapy parameters));
receiving an emergency stop and directly transmitting the emergency stop to the implantable microstimulator (para. 0128 (user interface in order to … turn stimulation off)).
Skelton does not teach a system for treating rheumatoid arthritis, a microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP), confirming that the external programmer is paired with the microstimulator, and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Huston teaches treating rheumatoid arthritis (abstract (A method and an apparatus for treating a patient suffering from, or at risk for, a condition mediated by the inflammatory cytokine cascade, by electrically stimulating vagus nerve activity in an amount sufficient to inhibit the inflammatory cytokine cascade), para. 0067 (conditions which can be usefully treated include… rheumatoid arthritis)) and apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP) (0010 (electrical vagus nerve stimulation was sufficient for activation of the cholinergic anti-inflammatory pathway), 0085 (cholinergic anti-inflammatory pathway activation is responsive to… electrical stimulation parameters)).
Huston does not teach a microstimulator, confirming that the external programmer is paired with the implantable microstimulator, and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Whitehurst teaches a system (para. 0001 (system)), the system comprising:
an implantable microstimulator (para. 001 (implantable microstimulator)) configured to apply stimulation (para. 0065 (stimulation)).
Whitehurst does not teach confirming that the external programmer is paired with the implantable microstimulator and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Wetmore teaches confirming that the external programmer is paired with the microstimulator (para. 0159 (A user indicates her request to pair a neuromodulation puck with the Bluetooth device… to confirm which puck is to be paired… to confirm successful pairing, the neuromodulation puck can be configured to generate a sound)), 0015 (puck – neuromodulation apparatus)).
Wetmore does not teach transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Moffitt teaches transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator (para. 0072 (programming device is configured to be communicatively coupled to modulation device), 0080 (implantable modulation device (implantable pulse generator)), 0078 (GUI includes… any type of user input that allow the user to program the modulation parameters… programming device may transmit the plurality of modulation parameters to the modulation device)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s system to incorporate the teachings of Huston and provide a system for treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway. Skeleton teaches a system to treat chronic pain but does not disclose treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway (para. 0039). Huston teaches that applying stimulation to the NCAP, reduces cytokine production (para. 0085). One of ordinary skill in the art would have been motivated to target the NCAP as Huston teaches that the NCAP’s effects are long lasting after stimulation (para. 0087). Therefore, such targeting would improve treatment specificity, providing a more effective therapeutic approach for managing rheumatoid arthritis.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst and provide a microstimulator. Skelton teaches an implantable stimulator device, but does not explicitly disclose a microstimulator. Therefore, incorporating the microstimulator taught by Whitehurst, would allow a minimal surgical procedure by implanting the microstimulator via a small incision, preventing more complicated surgical procedures, thereby reducing tissue trauma.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Wetmore and provide a way to confirm pairing of the external programmer with the microstimulator. Doing so would ensure a connection between the two components before any important user information is transmitted.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s user input to incorporate the teachings of Moffitt and provide a transmission of the user input to the implantable microstimulator through the external programmer. Doing so would the user inputs received by the external programmer to be communicated to the microstimulator, enabling an improved system of reliability without requiring the direct interaction with the microstimulator.
Regarding claim 14, Skelton teaches a method (para. 0006 (method)) using an implantable microstimulator (para. 0004 (implantable stimulator device)), the method comprising:
receiving, through the user interface on a user's mobile device, user input for delaying dosing by the implantable microstimulator or adjusting stimulation parameters of the implantable microstimulator for dosing delivered by the implantable microstimulator ((para. 0125 (programmer may be a cell phone), 0129 (receive input from a user), 0231 (receive input from a user defining a new time period, receive a selection of new therapy parameters)), wherein the user input for delaying dosing is received when an external programmer is not in communication with the implantable microstimulator (para. 0121 (telemetry circuit [within the IMD] may send information to and receive information from external programmer on a continuous basis… or upon request from the stimulator or programmer));
transmitting the user input from the user's mobile device ((para. 0125 (programmer may be a cell phone), 0129 (receive input from a user)); and
adjusting the implantable microstimulator based on the user input (para. 0047 (IMD generates and delivers stimulation therapy according to one or more programs. A program defines values for one or more parameters that define an aspect of the therapy delivered by IMD according to that program), 0057 (IMD may record and associate the therapy change), 0064 (IMD communicates with patient programmer to initialize therapy or modify therapy during operation)).
Skelton does not teach a method of treating rheumatoid arthritis, a microstimulator, confirming that the external programmer is paired with the implantable microstimulator, and transmitting the user input from the user's mobile device indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Huston teaches a method of treating rheumatoid arthritis (abstract (A method and an apparatus for treating a patient suffering from, or at risk for, a condition mediated by the inflammatory cytokine cascade, by electrically stimulating vagus nerve activity in an amount sufficient to inhibit the inflammatory cytokine cascade)).
Huston does not teach a microstimulator, confirming that the external programmer is paired with the implantable microstimulator, and transmitting the user input from the user's mobile device indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Whitehurst teaches an implantable microstimulator (para. 001 (implantable microstimulator)).
Whitehurst does not teach confirming that the external programmer is paired with the implantable microstimulator, and transmitting the user input from the user's mobile device indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Wetmore teaches confirming that the external programmer is paired with the implantable microstimulator (para. 0159 (A user indicates her request to pair a neuromodulation puck with the Bluetooth device… to confirm which puck is to be paired… to confirm successful pairing, the neuromodulation puck can be configured to generate a sound)), 0015 (puck – neuromodulation apparatus)).
Wetmore does not teach transmitting the user input from the user's mobile device indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Moffitt teaches transmitting the user input from the user's mobile device indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator (para. 0072 (programming device is configured to be communicatively coupled to modulation device), 0080 (implantable modulation device (implantable pulse generator)), 0078 (GUI includes… any type of user input that allow the user to program the modulation parameters… programming device may transmit the plurality of modulation parameters to the modulation device)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s method to incorporate the teachings of Huston and provide a method for treating rheumatoid arthritis. Skeleton teaches a system to treat chronic pain but does not disclose treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway (para. 0039). Huston teaches that applying stimulation to the NCAP, reduces cytokine production (para. 0085). One of ordinary skill in the art would have been motivated to target the NCAP as Huston teaches that the NCAP’s effects are long lasting after stimulation (para. 0087). Therefore, such targeting would improve treatment specificity, providing a more effective therapeutic approach for managing rheumatoid arthritis.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst and provide a microstimulator. Skelton teaches an implantable stimulator device, but does not explicitly disclose a microstimulator. Therefore, incorporating the microstimulator taught by Whitehurst, would allow a minimal surgical procedure by implanting the microstimulator via a small incision, preventing more complicated surgical procedures, thereby reducing tissue trauma.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Wetmore and provide a way to confirm pairing of the external programmer with the microstimulator. Doing so would ensure a connection between the two components before any important user information is transmitted.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s user input to incorporate the teachings of Moffitt and provide a transmission of the user input to the implantable microstimulator through the external programmer. Doing so would the user inputs received by the external programmer to be communicated to the microstimulator, enabling an improved system of reliability without requiring the direct interaction with the microstimulator.
Regarding claim 15, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the method of claim 14.
Skelton teaches wherein the implantable microstimulator is a leadless implantable microstimulator (para. 0043 (IMD may be a leadless stimulator).
Regarding claim 16, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the method of claim 14, wherein the external programmer (Fig. 6, element 20) comprises an inductive charger (para. 0122 (external inductive power supply), 0131 (external programmer may include a charger module capable of recharging a power source)).
Regarding claim 17, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the method of claim 14, further comprising receiving data associated with a patient metric and adjusting the dosing based on the patient metric (para. 0003 (allow for therapy activation, and/or adjustments to therapy parameters), 0058 (may transmit parameter adjustments to support therapy modification relating to changes in the posture state of patient), 0110 (processor may also adjust therapy for a new posture when posture state module indicates that patient has in fact changes postures… stimulation adjustments in response to posture state may be automatic or semi-automatic), 0226 (IMD receives a therapy adjustment from a programmer to define new therapy parameters)).
Regarding claim 18, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the method of claim 17.
Skeleton does not teach wherein the patient metric comprises a biomarker for inflammation.
Huston teaches wherein the patient metric comprises a biomarker for inflammation (Fig. 4, Fig. 5, para. 0051 (proinflammatory cytokine is TNF), 0083 (TNF concentrations)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Huston and provide a biomarker for inflammation. Doing so would have enabled monitoring of cytokine levels to identify trends that could indicate the effectiveness of the neural stimulation treatment to the user.
Regarding claim 20, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the method of claim 17, wherein the patient metric comprises an activity metric or a physiological metric (para. 0115 (posture state module may sensor physiological parameters of patient, may include heart rate, respiration rate)), 0109 (posture state module… may correspond to an activity and/or posture undertaken by patient)).
Regarding claim 21, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the method of claim 14.
Skelton teaches the system further comprising receiving, from the user interface, an emergency stop command and transmitting the emergency stop directly to the implantable microstimulator (para. 0128 (user interface in order to … turn stimulation off)).
Regarding claim 22, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the method of claim 14.
Skelton teaches the external programmer (Fig. 6, element 20).
Skelton does not teach the external programmer preventing improper modification of dosing.
Moffitt teaches wherein the external programmer is configured to prevent improper modification of dosing (para. 0078 (programming control circuit may check values of the plurality of modulation parameters against safety rules to limit these values within constraints of the safety rules), 0072 (delivery of the neuromodulation is controlled by using a plurality of modulation parameters)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s external programmer to incorporate the teachings of Moffitt to prevent improper modification of dosing. Doing so would provide a safety check to ensure that the patient is modifying the doses within the parameters of the stimulation therapy.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) and James et al. (James, E.A., et al. (2014), Citrulline-Specific Th1 Cells Are Increased in Rheumatoid Arthritis and Their Frequency Is Influenced by Disease Duration and Therapy. Arthritis & Rheumatology, 66: 1712-1722, https://doi.org/10.1002/art.38637), hereinafter James.
Regarding claim 8, Skelton (in view of Huston, Whitehurst, and Wetmore) teaches the system of claim 7.
Skelton does not teach wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
Huston teaches wherein the biomarker for inflammation comprises a cytokine level (Fig. 4, Fig. 5, para. 0051 (proinflammatory cytokine is TNF), 0083 (TNF concentrations)).
Huston does not teach wherein the biomarker for inflammation comprises a memory T cell level.
James teaches wherein the biomarker for inflammation comprises a memory T cell level (pg. 6 (included memory T cell markers), Fig. 3C).
Skelton, Huston, and James are all considered to be analogous to the claimed invention because they are in the same field of applying neural stimulation to a user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the combination of teachings and provide a cytokine level and a memory T cell level. Doing so would have enabled monitoring of cytokine and memory T cell levels to identify trends that could indicate the effectiveness of the neural stimulation treatment to the user.
Regarding claim 19, Skelton (in view of Huston, Whitehurst, Moffitt, and Wetmore) teaches the method of claim 17.
Skelton does not teach wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
Huston teaches wherein the biomarker for inflammation comprises a cytokine level (Fig. 4, Fig. 5, para. 0051 (proinflammatory cytokine is TNF), 0083 (TNF concentrations)).
Huston does not teach wherein the biomarker for inflammation comprises a memory T cell level.
James teaches wherein the biomarker for inflammation comprises a memory T cell level (pg. 6 (included memory T cell markers), Fig. 3C).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the combination of teachings and provide a cytokine level and a memory T cell level. Doing so would have enabled monitoring of cytokine and memory T cell levels to identify trends that could indicate the effectiveness of the neural stimulation treatment to the user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Levine et al. (https://doi.org/10.1371/journal.pone.0104530) and Tracey (US 20160250097 A9) are additional examples of treating rheumatoid arthritis. Bond et al. (US 20140371818 A1) and Panescu et al. (US 8019419 B1) are additional examples of pairing an IMD to an external programmer.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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