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 .
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites related application 16/955264 which has now matured into a patent. The paragraph should be updated to include the issued patent number. Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to because the unlabeled rectangular boxes shown in Fig. 2 should be provided with descriptive text labels to indicate what is contained or indicated by such boxes. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2 and 4-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0075702 to Shafer (herein Shafer) in view of US 2003/0088301 to King et al. (herein King) (both cited by applicant).
In reference to at least claim 1
Shafer discloses a system for stimulating the neural activity of a nerve supplying the spleen (e.g. para [0058] "Various postganglionic sympathetic neurons 148 that may be stimulated according to various embodiments of the invention include the splenic nerve, splanchnic nerves, and others named with respect to the tissue that it innervates."), wherein the nerve is associated with a neurovascular bundle (e.g. para [0064] "For example a stimulatory signal may be applied to the splenic neurovascular bundle at one or more locations along the length of the spleen; the splenic neurovascular bundle either proximal or distal to the bifurcation of the splenic artery and vein into upper and lower splenic branches; the periarterial splenic nerve"), the system comprising: at least one electrode in signaling contact with the nerve (e.g. para [0069] "FIG. 6B and FIGS. 7A through 7F, lead 16 provides electrical stimulation pulses to the desired target sites. Lead 16 and lead 18 may have unipolar electrodes disposed thereon where enclosure 14 is employed as an indifferent electrode) or may have multipolar, e.g. bipolar, electrodes disposed thereon, where one or more electrodes disposed on a lead are employed as the indifferent electrode": the target nerve in this case are nerves innervating the spleen); and at least one controller electrically coupled to the at least one electrode (e.g. Fig. 8 processor 31 is connected to output block 37), the at least one controller configured to control the operation of the least one electrode to apply an electrical signal to the nerve (e.g. para [0080] "An output pulse generator provides a stimulation signal to the desired target location 8 through, for example, a coupling capacitor in response to a trigger signal provided by a digital controller/timer circuit, when an externally transmitted stimulation command is received, or when a response to other stored commands is received).
However, Shafer does not explicitly teach wherein the charge density per phase applied to the nerve by the electrical signal is > 40 µC per cm2 per phase and < 150 µC per cm2 per phase.
King, within the same field of nerve stimulation, discloses wherein the charge density per phase applied to the nerve by the electrical signal is ≥ 40 µC per cm² per phase and is ≤ 150 µC per cm² per phase (e.g. Para [0056] "The charge density at an electrode of exposed surface area 8.0 square millimeters is thus 50 microcoulombs/square centimeter/pulse"). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Shafer to include a charge density of ≥ 40 µC per cm² per phase and is ≤ 150 µC per cm² per phase, as taught by King, in order to provide stimulation within safe limits that reduces damage to electrodes or tissues allowing the electrodes to stay safe and reliable (‘301, para [0056]). The language after “wherein the electrical signal produces” is a result of the electrical signal applied to the nerve since Shafer modified King discloses the claimed invention of providing an electrical signal having a charge density to a nerve, wherein the charge density per phase applied to the nerve by the electrical signal is > 40 µC per cm2 per phase and < 150 µC per cm2 per phase it would provide an electrical signal that will produce the results as claimed. In other words, Shafer modified by King as described above necessarily results in "an improvement in a physiological parameter in a subject, wherein the improvement in the physiological parameter is one or more of the group consisting of: a reduction in pro-inflammatory cytokines, an increase in anti- inflammatory cytokines and/or pro-resolving mediators, an increase in catecholamines, changes in immune cell population or immune cell surface co-stimulatory molecules, a reduction in factors involved in an inflammation cascade, and/or a reduction in immune response mediators" as is required by the claim because these results are a direct response to the provided stimulation. Thus, if stimulation is provided with the claimed stimulation parameters, the results would necessarily occur as claimed.
In reference to at least claim 2
Shafer modified by King renders obvious a system according to claim 1. Shafer further discloses wherein the electrical signal comprises a pulse train comprising a plurality of pulses (e.g. para [0081] "provide means for generating an appropriate train of stimulating pulses to the desired target location").
In reference to at least claim 4
Shafer in view of King discloses a method of reversibly stimulating neural activity in a nerve supplying the spleen (e.g. Shafer: Para [0103] "If, at any time after stimulation therapy is initiated 210, an improvement 220 is detected, the stimulation signal may be decreased 270. The extent to which the stimulation signal may be decreased 270 may be determined prior to initiation of stimulation 210 therapy or may be determined during therapy as conditions warrant"), wherein the nerve is associated with a neurovascular bundle (Shafer: Para [0064] "The splenic nerve may be stimulated directly or indirectly. For example a stimulatory signal may be applied to the splenic neurovascular bundle at one or more locations along the length of the spleen; the splenic neurovascular bundle either proximal or distal to the bifurcation of the splenic artery and vein into upper and lower splenic branches; the periarterial splenic nerve"), the method comprising: providing the system of claim 1 (see above rejection of claim 1); positioning at least one electrode in signaling contact with the nerve (Shafer: Para [0067] "Typically, pulse generators are coupled to one or more leads, with the leads being positioned to stimulate a sympathetic neuron, either directly or indirectly"); and controlling the operation of the least one electrode with at least one controller to apply an electrical signal to the nerve to stimulate neural activity (e.g. Shafer: Para [0122] "Microprocessor 700 may also program a pulse width control module 714 using bus 702. The pulse width control provides an enabling pulse of duration equal to the pulse width via a conductor 716. Pulses with the selected characteristics are then delivered from pulse generator 101 through lead 16 to stimulate a sympathetic nervous system 10 or one or more neuron associated therewith").
In reference to at least claim 5
Shafer modified by King renders obvious a method according to claim 4. Shafer further discloses wherein the method is for treating inflammatory disorders in a subject (e.g. para [0008] "However, as presented herein, stimulation of the sympathetic nervous system, particularly the splenic nerve, the fibers of which are predominantly efferent, may serve to attenuate an inflammatory immune response while providing less potentially undesired effects than would stimulation of the parasympathetic nervous system, particularly the vagus nerve").
In reference to at least claim 6
Shafer modified by King renders obvious a method according to claim 5. Shafer further discloses wherein the inflammatory disorder is selected from the group of arthritis. rheumatoid arthritis, osteoarthritis, psoriatic arthritis, Grave's disease, myasthenia gravis, thryoiditis, systemic lupus erythematosus, Goodpasture's syndrome, Behcets's syndrome, allograft rejection, graft-versus-host disease, ankylosing spondylitis, Berger's disease, diabetes including Type I diabetes, Reitier's syndrome, spondyloarthropathy psoriasis, multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, Addison's disease, autoimmune mediated hair loss, alopecia areata, and ulcerative colitis (e.g. para [0044] "Attenuation of an inflammatory immune response 20 includes attenuation of a deleterious characteristic of a disorder and/or disease state associated with a heightened inflammatory immune response 20. Deleterious characteristics include inflammation and apoptosis. Disorders or disease states associated with an inflammatory immune response 20. Crohn's disease": see para [0044] for full list).
In reference to at least claim 7
Shafer modified by King renders obvious a method according to claim 5. Shafer further discloses wherein the inflammatory disorder is selected from the group of asthma, allergy, anaphylactic shock, immune complex disease, sepsis, septicemia, endotoxic shock, eosinophilic granuloma, granulomatosis, organ ischemia, reperfusion injury, organ necrosis, hay fever, cachexia, hyperexia, septic abortion, HIV infection, herpes infection, organ transplant rejection, disseminated bacteremia, Dengue fever, malaria and sarcoidosis (e.g. para [0044] "Attenuation of an inflammatory immune response 20 includes attenuation of a deleterious characteristic of a disorder and/or disease state associated with a heightened inflammatory immune response 20. Deleterious characteristics include inflammation and apoptosis. Disorders or disease states associated with an inflammatory immune response 20...HIV": see para [0044] for full list).
In reference to at least claim 8
Shafer modified by King renders obvious a method according to claim 5. Shafer further discloses wherein the inflammatory disorder is an autoimmune disorder (e.g. para [0040]: see list of autoimmune disorders).
In reference to at least claim 9
Shafer modified by King renders obvious a method according to claim 8. Shafer further discloses wherein the autoimmune disorder is selected from the group of rheumatoid arthritis, osteoarthritis, psoriatic arthritis, spondyloarthropathy, ankylosing spondylitis, psoriasis, systemic lupus erythematosus (SLE), multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, ulcerative colitis and sepsis (e.g. para [0044] "Attenuation of an inflammatory immune response 20 includes attenuation of a deleterious characteristic of a disorder and/or disease state associated with a heightened inflammatory immune response 20. Deleterious characteristics include inflammation and apoptosis. Disorders or disease states associated with an inflammatory immune response 20 systemic lupus erythematosus": see para [0044] for full list).
In reference to at least claim 10
Shafer modified by King renders obvious a method according to claim 8. Shafer further discloses wherein the autoimmune disorder is systemic lupus erythematosus (SLE) (e.g. para [0044] "Attenuation of an inflammatory immune response 20 includes attenuation of a deleterious characteristic of a disorder and/or disease state associated with a heightened inflammatory immune response 20. Deleterious characteristics include inflammation and apoptosis. Disorders or disease states associated with an inflammatory immune response 20 systemic lupus erythematosus": see para [0044] for full list).
In reference to at least claim 11
Shafer modified by King renders obvious a method according to claim 5. Shafer further discloses wherein the inflammatory disorder is rheumatoid arthritis (e.g. para [0044] "Attenuation of an inflammatory immune response 20 includes attenuation of a deleterious characteristic of a disorder and/or disease state associated with a heightened inflammatory immune response 20. Deleterious characteristics include inflammation and apoptosis…. diseases of the bones, joints, muscles and connective tissues (such as the various arthritides and arthralgias, osteomyelitis, fasciitis, Paget's disease, gout, periodontal disease, rheumatoid arthritis, and synovitis)": see para [0044] for full list).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0075702 to Shafer (herein Shafer) in view of US 2003/0088301 to King et al. (herein King) as applied to claim 1 further in view of US 2010/0125304 to Faltys et al. (herein Faltys) (cited by applicant).
In reference to at least claim 3
Shafer in view of King discloses a method of providing the system of claim (see above rejection of claim 1). Shafer further discloses wherein the nerve is associated with a neurovascular bundle (e.g. para. [0064], "The splenic nerve may be stimulated directly or indirectly. For example a stimulatory signal may be applied to the splenic neurovascular bundle at one or more locations along the length of the spleen; the splenic neurovascular bundle either proximal or distal to the bifurcation of the splenic artery and vein into upper and lower splenic branches; the periarterial splenic nerve"); positioning the neural interface in signaling contact with the nerve (e.g. para [0067] "Typically, pulse generators are coupled to one or more leads, with the leads being positioned to stimulate a sympathetic neuron, either directly or indirectly"); controlling the operation of the least one electrode with at least one controller to apply an electrical signal to the nerve (e.g. para [0122] "Microprocessor 700 may also program a pulse width control module 714 using bus 702. The pulse width control provides an enabling pulse of duration equal to the pulse width via a conductor 716. Pulses with the selected characteristics are then delivered from pulse generator 101 through lead 16 to stimulate a sympathetic nervous system 10 or one or more neuron associated therewith"); determining at least one of: blood flow rate in the spleen, blood flow rate in the splenic artery, blood flow rate in the splenic vein, spleen volume, neural activity in the nerve, or impedance of the at least one electrode (e.g. para. [0110] "Sensor 300 may detect biochemical parameters, physiological parameters, and combinations thereof. Biological parameters include pH, a chemical, an ion, a biological molecule, a gas, spectral indicators thereof, and combinations thereof. Physiological parameters such as body temperature, heart rate, blood pressure, cardiac output, electrical activity of a neuron, and the like, or combinations thereof"). However, Shafer does not explicitly disclose a method of determining whether a neural interface is correctly placed in signaling contact with a nerve supplying the spleen and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve.
Faltys, within a same field of endeavor or neuronal stimulation, discloses a method of determining whether a neural interface is correctly placed in signaling contact with a nerve supplying the spleen (e.g. para [0013] "Described herein are systems, devices and methods for optimizing the position of electrodes for stimulating the inflammatory reflex to inhibit or otherwise modulate inflammation. In particular, described herein are systems, devices and methods for optimizing the position of one or more electrodes relative to one or more portion of the inflammatory reflex, such as the vagus nerve, the splenic nerve, the hepatic nerve and the trigeminal nerve"), the method comprising: and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve (e.g. para [0014] "In some variations, the position of the stimulation electrode (or electrodes) is optimized by detecting and/or measuring "stimulation artifacts" during insertion/implantation and programming of the electrode. Certain of the devices, systems and methods allow for the feedback of information to the clinician or to an analysis device in real-time during or after implantation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Shafer modified by King to further include a method of determining whether a neural interface is correctly placed in signaling contact with a nerve supplying the spleen, the method comprising: and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve, as taught by Faltys, in order to optimize the placement of electrodes to stimulate the inflammatory reflex and thereby inhibit inflammation, while minimizing or eliminating undesirable or unwanted side effects (‘304, para [0032])
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,446,502. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 11,446,502 recite similar systems and methods of stimulating a nerve supply a spleen using at least one electrode in signaling contact with a nerve and a controller controlling operation of providing an electrical signal with a certain charge density per phase with the only differences being that the range of the charge density per phase claimed within the claims within the instant application reciting a range that overlaps and has certain values that are within the range recited within U.S. Patent No. 11,446,502, therefore the claims within U.S. Patent No. 11,446,502 have a scope that anticipates certain range values recited in the instant application fully anticipating the claims within the instant application while other range values are at least obvious, see claim chart below for claim to claim comparison.
Instant Application
U.S. Patent No. 11,446,502
Analysis
1. A system for stimulating neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the system comprising: at least one electrode configured to be in signaling contact with the nerve; and at least one controller electrically coupled to the at least one electrode, the at least one controller configured to control operation of the at least one electrode to apply an electrical signal having a charge density to the nerve, wherein the charge density per phase applied to the nerve by the electrical signal is > 40 µC per cm2 per phase and < 150 µC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject, wherein the improvement in the physiological parameter is one or more of the group consisting of: a reduction in pro-inflammatory cytokines, an increase in anti-inflammatory cytokines and/or pro-resolving mediators, an increase in catecholamines, changes in immune cell population or immune cell surface co-stimulatory molecules, a reduction in factors involved in an inflammation cascade, and/or a reduction in immune response mediators.
1. A system for stimulating neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the system comprising: at least one electrode configured to be in signaling contact with the nerve supplying the spleen; and at least one controller electrically coupled to the at least one electrode, the at least one controller configured to control operation of the at least one electrode to apply an electrical signal having a charge density to the nerve, wherein the charge density per phase applied to the nerve by the electrical signal is ≥70 μC per cm.sup.2 per phase and >1100 μC per cm.sup.2 per phase, the electrical signal capable of producing an improvement in a physiological parameter in a subject, wherein the improvement in the physiological parameter is one or more of the group consisting of: a reduction in pro-inflammatory cytokines, an increase in anti-inflammatory cytokines and/or pro-resolving mediators, an increase in catecholamines, changes in immune cell population or immune cell surface co-stimulatory molecules, a reduction in factors involved in an inflammation cascade, and/or a reduction in immune response mediators.
2. The system of claim 1, where the charge density per phase is ≥70 μC per cm.sup.2 per phase and ≤500 μC per cm.sup.2 per phase.
3. The system of claim 1, where the charge density per phase is ≥70 μC per cm.sup.2 per phase and ≤250 μC per cm.sup.2 per phase.
4. The system of claim 1, where the charge density per phase is ≥70 μC per cm.sup.2 per phase and ≤170 μC per cm.sup.2 per phase.
Both the claims in the instant application and those within U.S. Patent No. 11,446,502 recite similar systems and methods of stimulating a nerve supply a spleen using at least one electrode in signaling contact with a nerve and a controller controlling operation of providing an electrical signal with a certain charge density per phase with the only differences being that the range of the charge density per phase claimed within the claims within the instant application reciting a range that overlaps and has certain values that are within the range recited within U.S. Patent No. 11,446,502, therefore the claims within U.S. Patent No. 11,446,502 have a scope that anticipates certain range values recited in the instant application fully anticipating the claims within the instant application while other range values are at least obvious, see claim chart below for claim to claim comparison.
2. The system of claim 1, wherein the electrical signal comprises a pulse train comprising a plurality of pulses.
5. The system of claim 1, wherein the electrical signal comprises a pulse train comprising a plurality of pulses.
See analysis above regarding claim 1. Claim 5 of U.S. Patent No. 11,446,502 discloses the limitations within claim 2 of the instant application.
3. A method of determining whether a neural interface is correctly placed in signaling contact with a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the neural interface in signaling contact with the nerve; controlling the operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve; determining at least one of: blood flowrate in the spleen, blood flow rate in a splenic artery, blood flowrate in a splenic vein, spleen volume, neural activity in the nerve, or impedance of the at least one electrode; and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve.
6. A method of determining whether a neural interface is correctly placed in signaling contact with a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the neural interface in signaling contact with the nerve; controlling the operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve; determining at least one of: blood flowrate in the spleen, blood flow rate in a splenic artery, blood flowrate in a splenic vein, spleen volume, neural activity in the nerve, or impedance of the at least one electrode; and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve.
See analysis above regarding claim 1. Claim 6 of U.S. Patent No. 11,446,502 discloses the limitations within claim 3 of the instant application.
4. A method of reversibly stimulating neural activity in a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the at least one electrode in signaling contact with the nerve; and controlling operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve to stimulate neural activity.
7. A method of reversibly stimulating neural activity in a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the at least one electrode in signaling contact with the nerve; and controlling operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve to stimulate neural activity.
See analysis above regarding claim 1. Claim 7 of U.S. Patent No. 11,446,502 discloses the limitations within claim 4 of the instant application.
5. The method of claim 4, wherein the method is for treating inflammatory disorders in a subject.
8. The method of claim 7, wherein the method is for treating inflammatory disorders in a subject.
See analysis above regarding claim 4. Claim 8 of U.S. Patent No. 11,446,502 discloses the limitations within claim 5 of the instant application.
6. The method of claim 5, wherein the inflammatory disorder is selected from the group of: arthritis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis, Grave's disease, myasthenia gravis, thryoiditis, systemic lupus erythematosus, Goodpasture's syndrome, Behcets's syndrome, allograft rejection, graft-versus-host disease, ankylosing spondylitis, Berger's disease, diabetes including Type I diabetes, Reitier's syndrome, spondyloarthropathy, psoriasis, multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, Addison's disease, autoimmune mediated hair loss, alopecia areata, and ulcerative colitis.
9. The method of claim 8, wherein the inflammatory disorder is selected from the group of: arthritis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis, Grave's disease, myasthenia gravis, thryoiditis, systemic lupus erythematosus, Goodpasture's syndrome, Behcets's syndrome, allograft rejection, graft-versus-host disease, ankylosing spondylitis, Berger's disease, diabetes including Type I diabetes, Reitier's syndrome, spondyloarthropathy, psoriasis, multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, Addison's disease, autoimmune mediated hair loss, alopecia areata, and ulcerative colitis.
See analysis above regarding claim 5. Claim 9 of U.S. Patent No. 11,446,502 discloses the limitations within claim 6 of the instant application.
7. The method of claim 5, wherein the inflammatory disorder is selected from the group of: asthma, allergy, anaphylactic shock, immune complex disease, sepsis, septicemia, endotoxic shock, eosinophilic granuloma, granulomatosis, organ ischemia, reperfusion injury, organ necrosis, hay fever, cachexia, hyperexia, septic abortion, HIV infection, herpes infection, organ transplant rejection, disseminated bacteremia, Dengue fever, malaria, and sarcoidosis.
10. The method of claim 8, wherein the inflammatory disorder is selected from the group of: asthma, allergy, anaphylactic shock, immune complex disease, sepsis, septicemia, endotoxic shock, eosinophilic granuloma, granulomatosis, organ ischemia, reperfusion injury, organ necrosis, hay fever, cachexia, hyperexia, septic abortion, HIV infection, herpes infection, organ transplant rejection, disseminated bacteremia, Dengue fever, malaria, and sarcoidosis.
See analysis above regarding claim 5. Claim 10 of U.S. Patent No. 11,446,502 discloses the limitations within claim 7 of the instant application.
8. The method of claim 5, wherein the inflammatory disorder is an autoimmune disorder.
11. The method of claim 8, wherein the inflammatory disorder is an autoimmune disorder.
See analysis above regarding claim 5. Claim 11 of U.S. Patent No. 11,446,502 discloses the limitations within claim 8 of the instant application.
9. The method of claim 8, wherein the autoimmune disorder is selected from the group of: rheumatoid arthritis, osteoarthritis, psoriatic arthritis, spondyloarthropathy, ankylosing spondylitis, psoriasis, systemic lupus erythematosus (SLE), multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, ulcerative colitis, and sepsis.
12. The method of claim 11, wherein the autoimmune disorder is selected from the group of: rheumatoid arthritis, osteoarthritis, psoriatic arthritis, spondyloarthropathy, ankylosing spondylitis, psoriasis, systemic lupus erythematosus (SLE), multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, ulcerative colitis, and sepsis.
See analysis above regarding claim 8. Claim 12 of U.S. Patent No. 11,446,502 discloses the limitations within claim 9 of the instant application.
10. The method of claim 8, wherein the autoimmune disorder is systemic lupus erythematosus (SLE).
13. The method of claim 11, wherein the autoimmune disorder is systemic lupus erythematosus (SLE) or rheumatoid arthritis.
See analysis above regarding claim 8. Claim 13 of U.S. Patent No. 11,446,502 discloses the limitations within claim 10 of the instant application.
11. The method of claim 5, wherein the inflammatory disorder is rheumatoid arthritis.
13. The method of claim 11, wherein the autoimmune disorder is systemic lupus erythematosus (SLE) or rheumatoid arthritis.
See analysis above regarding claim 5. Claim 13 of U.S. Patent No. 11,446,502 discloses the limitations within claim 11 of the instant application.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,296,171. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 12,296,171 recite similar systems and methods of stimulating a nerve supply a spleen using at least one electrode in signaling contact with a nerve and a controller controlling operation of providing an electrical signal with a certain charge density per phase with the only differences being that U.S. Patent No. 12,296,171 specifies a nerve supplying the spleen, therefore the claims within U.S. Patent No. 12,296,171 have a scope that fully anticipates the claims within the instant application, see claim chart below for claim to claim comparison.
Instant Application
U.S. Patent No. 12,296,171
Analysis
1. A system for stimulating neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the system comprising: at least one electrode configured to be in signaling contact with the nerve; and at least one controller electrically coupled to the at least one electrode, the at least one controller configured to control operation of the at least one electrode to apply an electrical signal having a charge density to the nerve, wherein the charge density per phase applied to the nerve by the electrical signal is > 40 µC per cm2 per phase and < 150 µC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject, wherein the improvement in the physiological parameter is one or more of the group consisting of: a reduction in pro-inflammatory cytokines, an increase in anti-inflammatory cytokines and/or pro-resolving mediators, an increase in catecholamines, changes in immune cell population or immune cell surface co-stimulatory molecules, a reduction in factors involved in an inflammation cascade, and/or a reduction in immune response mediators.
1. A system for stimulating neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the system comprising: at least one electrode configured to be in signaling contact with the nerve supplying the spleen, wherein the nerve is associated with the neurovascular bundle; and at least one controller electrically coupled to the at least one electrode, the at least one controller configured to control operation of the at least one electrode to apply an electrical signal having a charge density to the nerve, wherein the charge density per phase applied to the nerve supplying the spleen by the electrical signal is >40 μC per cm2 per phase and < 150 μC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject, wherein the improvement in the physiological parameter is one or more of the group consisting of: a reduction in pro-inflammatory cytokines, an increase in anti-inflammatory cytokines and/or pro-resolving mediators, an increase in catecholamines, changes in immune cell population or immune cell surface co-stimulatory molecules, a reduction in factors involved in an inflammation cascade, and/or a reduction in immune response mediators.
Both the claims in the instant application and those within U.S. Patent No. 12,296,171 recite similar systems and methods of stimulating a nerve supply a spleen using at least one electrode in signaling contact with a nerve and a controller controlling operation of providing an electrical signal with a certain charge density per phase with the only differences being that U.S. Patent No. 12,296,171 specifies a nerve supplying the spleen, therefore the claims within U.S. Patent No. 12,296,171 have a scope that fully anticipates the claims within the instant application.
2. The system of claim 1, wherein the electrical signal comprises a pulse train comprising a plurality of pulses.
2. The system of claim 1, wherein the electrical signal comprises a pulse train comprising a plurality of pulses.
See analysis above regarding claim 1. Claim 2 of U.S. Patent No. 12,296,171 discloses the limitations within claim 2 of the instant application.
3. A method of determining whether a neural interface is correctly placed in signaling contact with a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the neural interface in signaling contact with the nerve; controlling the operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve; determining at least one of: blood flowrate in the spleen, blood flow rate in a splenic artery, blood flowrate in a splenic vein, spleen volume, neural activity in the nerve, or impedance of the at least one electrode; and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve.
3. A method of determining whether a neural interface is correctly placed in signaling contact with a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the neural interface in signaling contact with the nerve; controlling the operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve; determining at least one of: blood flowrate in the spleen, blood flow rate in a splenic artery, blood flowrate in a splenic vein, spleen volume, neural activity in the nerve, or impedance of the at least one electrode; and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve.
See analysis above regarding claim 1. Claim 3 of U.S. Patent No. 12,296,171 discloses the limitations within claim 3 of the instant application.
4. A method of reversibly stimulating neural activity in a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the at least one electrode in signaling contact with the nerve; and controlling operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve to stimulate neural activity.
4. A method of reversibly stimulating neural activity in a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the at least one electrode in signaling contact with the nerve; and controlling operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve to stimulate neural activity.
See analysis above regarding claim 1. Claim 4 of U.S. Patent No. 12,296,171 discloses the limitations within claim 4 of the instant application.
5. The method of claim 4, wherein the method is for treating inflammatory disorders in a subject.
5. The method of claim 4, wherein the method is for treating inflammatory disorders in a subject.
See analysis above regarding claim 4. Claim 5 of U.S. Patent No. 12,296,171 discloses the limitations within claim 5 of the instant application.
6. The method of claim 5, wherein the inflammatory disorder is selected from the group of: arthritis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis, Grave's disease, myasthenia gravis, thryoiditis, systemic lupus erythematosus, Goodpasture's syndrome, Behcets's syndrome, allograft rejection, graft-versus-host disease, ankylosing spondylitis, Berger's disease, diabetes including Type I diabetes, Reitier's syndrome, spondyloarthropathy, psoriasis, multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, Addison's disease, autoimmune mediated hair loss, alopecia areata, and ulcerative colitis.
6. The method of claim 5, wherein the inflammatory disorder is selected from the group of: arthritis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis, Grave's disease, myasthenia gravis, thryoiditis, systemic lupus erythematosus, Goodpasture's syndrome, Behcets's syndrome, allograft rejection, graft-versus-host disease, ankylosing spondylitis, Berger's disease, diabetes including Type I diabetes, Reitier's syndrome, spondyloarthropathy, psoriasis, multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, Addison's disease, autoimmune mediated hair loss, alopecia areata, and ulcerative colitis.
See analysis above regarding claim 5. Claim 6 of U.S. Patent No. 12,296,171 discloses the limitations within claim 6 of the instant application.
7. The method of claim 5, wherein the inflammatory disorder is selected from the group of: asthma, allergy, anaphylactic shock, immune complex disease, sepsis, septicemia, endotoxic shock, eosinophilic granuloma, granulomatosis, organ ischemia, reperfusion injury, organ necrosis, hay fever, cachexia, hyperexia, septic abortion, HIV infection, herpes infection, organ transplant rejection, disseminated bacteremia, Dengue fever, malaria, and sarcoidosis.
7. The method of claim 5, wherein the inflammatory disorder is selected from the group of: asthma, allergy, anaphylactic shock, immune complex disease, sepsis, septicemia, endotoxic shock, eosinophilic granuloma, granulomatosis, organ ischemia, reperfusion injury, organ necrosis, hay fever, cachexia, hyperexia, septic abortion, HIV infection, herpes infection, organ transplant rejection, disseminated bacteremia, Dengue fever, malaria, and sarcoidosis.
See analysis above regarding claim 5. Claim 7 of U.S. Patent No. 12,296,171 discloses the limitations within claim 7 of the instant application.
8. The method of claim 5, wherein the inflammatory disorder is an autoimmune disorder.
8. The method of claim 5, wherein the inflammatory disorder is an autoimmune disorder.
See analysis above regarding claim 5. Claim 8 of U.S. Patent No. 12,296,171 discloses the limitations within claim 8 of the instant application.
9. The method of claim 8, wherein the autoimmune disorder is selected from the group of: rheumatoid arthritis, osteoarthritis, psoriatic arthritis, spondyloarthropathy, ankylosing spondylitis, psoriasis, systemic lupus erythematosus (SLE), multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, ulcerative colitis, and sepsis.
9. The method of claim 8, wherein the autoimmune disorder is selected from the group of: rheumatoid arthritis, osteoarthritis, psoriatic arthritis, spondyloarthropathy, ankylosing spondylitis, psoriasis, systemic lupus erythematosus (SLE), multiple sclerosis, Inflammatory Bowel Disease, Crohn's disease, ulcerative colitis, and sepsis.
See analysis above regarding claim 8. Claim 2 of U.S. Patent No. 12,296,171 discloses the limitations within claim 2 of the instant application.
10. The method of claim 8, wherein the autoimmune disorder is systemic lupus erythematosus (SLE).
10. The method of claim 8, wherein the autoimmune disorder is systemic lupus erythematosus (SLE) or rheumatoid arthritis.
See analysis above regarding claim 8. Claim 10 of U.S. Patent No. 12,296,171 discloses the limitations within claim 10 of the instant application.
11. The method of claim 5, wherein the inflammatory disorder is rheumatoid arthritis.
11. The method of claim 5, wherein the autoimmune disorder is systemic lupus erythematosus (SLE) or rheumatoid arthritis.
See analysis above regarding claim 5. Claim 11 of U.S. Patent No. 12,296,171 discloses the limitations within claim 11 of the instant application.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4 and 12-14 of U.S. Patent No. 11,738,196. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 11,738,196 recite similar systems and methods of stimulating a nerve supply a spleen using at least one electrode in signaling contact with a nerve and a controller controlling operation of providing an electrical signal with a certain charge density per phase with the only differences being that U.S. Patent No. 11,738,196 specifies a splenic arterial nerve, has additional limitations related to a splenic blood flow and the range of the charge density per phase claimed within the claims within the instant application recite a range that falls within and has certain values that are within the range recited within U.S. Patent No. 11,738,196, therefore the claims within U.S. Patent No. 11,738,196 have a scope that anticipates certain range values recited in the instant application fully anticipating the claims within the instant application while other range values are at least obvious, see claim chart below for claim to claim comparison.
Instant Application
U.S. Patent No. 11,738,196
Analysis
1. A system for stimulating neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the system comprising: at least one electrode configured to be in signaling contact with the nerve; and at least one controller electrically coupled to the at least one electrode, the at least one controller configured to control operation of the at least one electrode to apply an electrical signal having a charge density to the nerve, wherein the charge density per phase applied to the nerve by the electrical signal is > 40 µC per cm2 per phase and < 150 µC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject, wherein the improvement in the physiological parameter is one or more of the group consisting of: a reduction in pro-inflammatory cytokines, an increase in anti-inflammatory cytokines and/or pro-resolving mediators, an increase in catecholamines, changes in immune cell population or immune cell surface co-stimulatory molecules, a reduction in factors involved in an inflammation cascade, and/or a reduction in immune response mediators.
1. A system for stimulating the neural activity of a splenic arterial nerve, the system comprising: at least one electrode in signaling contact with the nerve at a site where the splenic artery is not in direct contact with the pancreas; and at least one controller electrically coupled to the at least one electrode, the at least one controller configured to control the operation of the least one electrode to apply an electrical signal to the nerve, wherein a charge density per phase applied to the nerve by the electrical signal is between 5 μC to 1100 μC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject, and wherein the improvement in the physiological parameter is one or more of a group consisting of: a reduction in a pro-inflammatory cytokine, an increase in an anti-inflammatory cytokine, an increase in a catecholamine, a change in an immune cell population, a change in an immune cell surface co-stimulatory molecule, a reduction in a factor involved in the inflammation cascade, a change in a level of an immune response mediator, and a decrease in splenic blood flow.
Both the claims in the instant application and those within U.S. Patent No. 11,738,196 recite similar systems and methods of stimulating a nerve supply a spleen using at least one electrode in signaling contact with a nerve and a controller controlling operation of providing an electrical signal with a certain charge density per phase with the only differences being that U.S. Patent No. 11,738,196 specifies a splenic arterial nerve, has additional limitations related to a splenic blood flow and the range of the charge density per phase claimed within the claims within the instant application recite a range that falls within and has certain values that are within the range recited within U.S. Patent No. 11,738,196, therefore the claims within U.S. Patent No. 11,738,196 have a scope that anticipates certain range values recited in the instant application fully anticipating the claims within the instant application while other range values are at least obvious.
2. The system of claim 1, wherein the electrical signal comprises a pulse train comprising a plurality of pulses.
4. The system of claim 1, wherein the electrical signal comprises a pulse train, the pulse train comprising a plurality of pulses.
See analysis above regarding claim 1. Claim 4 of U.S. Patent No. 11,738,196 discloses the limitations within claim 2 of the instant application.
3. A method of determining whether a neural interface is correctly placed in signaling contact with a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the neural interface in signaling contact with the nerve; controlling the operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve; determining at least one of: blood flowrate in the spleen, blood flow rate in a splenic artery, blood flowrate in a splenic vein, spleen volume, neural activity in the nerve, or impedance of the at least one electrode; and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve.
14. A method of determining whether a neural interface is correctly placed in signaling contact with a splenic arterial nerve at a site where the splenic artery is not in direct contact with the pancreas, the method comprising: providing the system of claim 1; positioning the neural interface around a nerve at a site where the splenic artery is not in direct contact with the pancreas; controlling the operation of the least one electrode with at least one controller to apply an electrical signal to the nerve; determining one or more of a: a change in blood flow rate or pressure in the spleen, splenic artery, or splenic vein, a decrease in spleen volume, an increase in neural activity in the nerve, a change of heart rate, a change of systemic arterial blood pressure, a decrease in impedance of the at least one electrode, and a decrease in a stimulator voltage compliance; and indicating to an operator that the neural interface had been placed correctly in signaling contact with the nerve.
See analysis above regarding claim 1. Claim 14 of U.S. Patent No. 11,738,196 discloses the limitations within claim 3 of the instant application.
4. A method of reversibly stimulating neural activity in a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the at least one electrode in signaling contact with the nerve; and controlling operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve to stimulate neural activity.
12. A method of reversibly stimulating neural activity in a nerve supplying the spleen, the method comprising: providing the system of claim 1; positioning at least one electrode in signaling contact with the nerve adjacent to a splenic arterial loop; and controlling the operation of the least one electrode with at least one controller to apply an electrical signal to the nerve to reversibly stimulate neural activity.
See analysis above regarding claim 1. Claim 12 of U.S. Patent No. 11,738,196 discloses the limitations within claim 4 of the instant application.
5. The method of claim 4, wherein the method is for treating inflammatory disorders in a subject.
13. The method of claim 12, wherein the method is for treating a disorder associated with inflammation in a subject.
See analysis above regarding claim 1. Claim 12 of U.S. Patent No. 11,738,196 discloses the limitations within claim 5 of the instant application.
Claims 1-2 and 4-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4 and 6 of U.S. Patent No. 12,161,869. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 12,161,869 recite similar systems and methods of stimulating a nerve supply a spleen using at least one electrode in signaling contact with a nerve and a controller controlling operation of providing an electrical signal with a certain charge density per phase with the only differences being that U.S. Patent No. 12,161,869 specifies a splenic arterial nerve, has additional limitations related to a splenic blood flow and an anti-inflammatory medicine and the range of the charge density per phase claimed within the claims within the instant application recite a range that falls within and has certain values that are within the range recited within U.S. Patent No. 12,161,869, therefore the claims within U.S. Patent No. 12,161,869 have a scope that anticipates certain range values recited in the instant application fully anticipating the claims within the instant application while other range values are at least obvious, see claim chart below for claim to claim comparison.
Instant Application
U.S. Patent No. 12,161,869
Analysis
1. A system for stimulating neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the system comprising: at least one electrode configured to be in signaling contact with the nerve; and at least one controller electrically coupled to the at least one electrode, the at least one controller configured to control operation of the at least one electrode to apply an electrical signal having a charge density to the nerve, wherein the charge density per phase applied to the nerve by the electrical signal is > 40 µC per cm2 per phase and < 150 µC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject, wherein the improvement in the physiological parameter is one or more of the group consisting of: a reduction in pro-inflammatory cytokines, an increase in anti-inflammatory cytokines and/or pro-resolving mediators, an increase in catecholamines, changes in immune cell population or immune cell surface co-stimulatory molecules, a reduction in factors involved in an inflammation cascade, and/or a reduction in immune response mediators.
1. A system for stimulating the neural activity of a splenic arterial nerve in combination with an anti-inflammatory medicine, the system comprising: at least one electrode in signaling contact with the nerve at a site where the splenic artery is not in direct contact with the pancreas; and at least one controller electrically coupled to the at least one electrode, the at least one controller configured to control the operation of the least one electrode to apply an electrical signal to the nerve, wherein a charge density per phase applied to the nerve by the electrical signal is between 5 μC to 1100 μC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject, and wherein the improvement in the physiological parameter is one or more of a group consisting of: a reduction in a pro-inflammatory cytokine, an increase in an anti-inflammatory cytokine, an increase in a catecholamine, a change in an immune cell population, a change in an immune cell surface co-stimulatory molecule, a reduction in a factor involved in the inflammation cascade, a change in a level of an immune response mediator, and a decrease in splenic blood flow, wherein the system is capable for use in combination with the anti-inflammatory medicine.
Both the claims in the instant application and those within U.S. Patent No. 12,161,869 recite similar systems and methods of stimulating a nerve supply a spleen using at least one electrode in signaling contact with a nerve and a controller controlling operation of providing an electrical signal with a certain charge density per phase with the only differences being that U.S. Patent No. 12,161,869 specifies a splenic arterial nerve, has additional limitations related to a splenic blood flow and an anti-inflammatory medicine and the range of the charge density per phase claimed within the claims within the instant application recite a range that falls within and has certain values that are within the range recited within U.S. Patent No. 12,161,869, therefore the claims within U.S. Patent No. 12,161,869 have a scope that anticipates certain range values recited in the instant application fully anticipating the claims within the instant application while other range values are at least obvious, see claim chart below for claim to claim comparison.
2. The system of claim 1, wherein the electrical signal comprises a pulse train comprising a plurality of pulses.
4. The system of claim 1, wherein the electrical signal comprises a pulse train, the pulse train comprising a plurality of pulses.
See analysis above regarding claim 1. Claim 4 of U.S. Patent No. 12,161,869 discloses the limitations within claim 2 of the instant application.
4. A method of reversibly stimulating neural activity in a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, the method comprising: providing the system of claim 1; positioning the at least one electrode in signaling contact with the nerve; and controlling operation of the at least one electrode with the at least one controller to apply an electrical signal to the nerve to stimulate neural activity.
6. A method of reversibly stimulating neural activity in a nerve supplying the spleen, the method comprising: providing the system of claim 1; positioning at least one electrode in signaling contact with the nerve adjacent to a splenic arterial loop; and controlling the operation of the least one electrode with at least one controller to apply an electrical signal to the nerve to reversibly stimulate neural activity, and wherein the method is for treating a disorder associated with inflammation and further comprises use of an anti-inflammatory medicine.
See analysis above regarding claim 1. Claim 6 of U.S. Patent No. 12,161,869 discloses the limitations within claim 4 of the instant application.
5. The method of claim 4, wherein the method is for treating inflammatory disorders in a subject.
6. A method of reversibly stimulating neural activity in a nerve supplying the spleen, the method comprising: providing the system of claim 1…. wherein the method is for treating a disorder associated with inflammation and further comprises use of an anti-inflammatory medicine.
See analysis above regarding claim 4. Claim 6 of U.S. Patent No. 12,161,869 discloses the limitations within claim 5 of the instant application.
Conclusion
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