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 .
This office action is in response to applicant’s communication of 7/19/2024. Currently claims 62-71, 74-78, and 81-86 are pending and rejected below.
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 62-71, 74-78, and 81-86 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 62, 68, and 86, the phrase "TNF" renders the claim indefinite because it is unclear what “TNF” means from the claim. Examiner is taking the position that “TNF” means Tumor Necrosis Factor but it is recommended that applicant amend the claims to clarify what “TNF” stands for.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 62-71, 74-78, and 81-86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tracey et al. (US 2016/0096016 A1).
Tracy discloses a method of reducing inflammation in a patient that is intolerant to or has failed to adequately respond to either TNF inhibition, the method comprising: identifying that the patient has failed to respond to TNF inhibitor therapy comprising a drug that inhibits TNF; administering a treatment regimen to activate a neuroimmune anti-inflammatory pathway in the patient by applying electrical energy to one of: a vagus nerve, a splenic nerve, a radial nerve, a median nerve, an ulnar nerve, a femoral nerve, a sciatic nerve, a tibial nerve, a splanchnic nerve, a phrenic nerve, a hepatic nerve, a renal nerve, a greater auricular nerve, a lesser occipital nerve, or an auriculotemporal nerve, wherein applying electrical energy comprises applying charge ranging from 0.2 nanocoulombs and 5 kilocoulomb per hour (see abstract, and para [0008], [0046], [0015], [0064]).
Concerning claim 1, TRACEY teaches a method of reducing inflammation in a patient the method comprising administering a treatment regimen by applying electrical energy to activate a neuroimmune anti-inflammatory pathway in the patient (abstract, "Described herein are devices, systems and method of treating inflammation by vagus nerve stimulation and the delivery of an anti-inflammatory drug ... treating inflammation including the steps of stimulating a subject's inflammatory reflex to inhibit the immune response and administering an anti-inflammatory drug"; para (0008], "the stimulation of the subject's inflammatory reflex may be electrical stimulation"; para [0046], "The stimulation of the inflammatory pathway may be provided by an external device, an internal (e.g., implanted) device, or a device having both internal and external components") and administering a TNF inhibitor (abstract; para [0064], "In some embodiments, the drugs delivered in conjunction with vagus nerve stimulation include anti-inflammatory drugs such as TNF blockers ... TABLE 2 ... TNF ... Examples of drugs ... etanercept, adalimumab, infliximab, golimumab, certolizumab, pegol"; see instant specification para [0015]); but does not explicitly teach identifying the patient has failed to respond to TNF inhibitor therapy comprising a drug that inhibits TNF, and applying electrical energy to the patient that is intolerant to or has failed to respond to TNF inhibition.
However, TRACEY teaches capability of showing inflammatory reflex as measured by serum TNF (abstract, "described herein are methods of treating inflammation including the steps of stimulating a subject's inflammatory reflex"; para (0015], "FIG. 1 shows the loss of inhibition the inflammatory reflex (measured by serum TNF)"). Furthermore, TRACEY teaches two treatments comprising an independent TNF inhibitory therapy by use of TNF blockers, capable of blocking immune cell function or destruction of immune cells, thereby resulting in fewer TNF in the patient (abstract, "treating inflammation by vagus nerve stimulation and the delivery of an anti-inflammatory drug"; para [0064], "the drugs delivered in conjunction with vagus nerve stimulation include anti-inflammatory drugs such as TNF blockers or IL-6 inhibitors. This treatment may combine two independent therapies for treating inflammation. Other drugs include drugs which suppress immune function by blocking one or more immune mediators, or immune cell function, or alternatively, target an immune cell for destruction, thereby suppressing immune function";;para [0004], "TNF producing macrophages").
Therefore, ii would have been obvious to one of ordinary skill in the art to observe or identify failure/intolerance to the TNF inhibitor in a patient as measured by serum TNF resulting from any previous TNF inhibitor treatments by routine experimentation to show efficacy or intolerance to the TNF inhibitory therapy and therefore optimize the regimen of the second treatment (ie stimulation) to said patients (abstract, "treating inflammation by vagus nerve stimulation and the delivery of an anti-inflammatory drug"; para [0064], "the drugs delivered in conjunction with vagus nerve stimulation include anti-inflammatory drugs such as TNF blockers or IL-6 inhibitors. This treatment may combine two independent therapies for treating inflammation").
Concerning wherein applying electrical energy comprises applying a charge ranging from 0.2 nanocoulombs and 5 kilocoulomb. TRACEY teaches the method, wherein applying electrical energy comprises applying nerve stimulations {abstract; para [0008]), but does not explicitly teach wherein applying electrical energy comprises applying a charge ranging from 0.2 nanocoulombs and 5 kilocoulomb. However, ii would have been obvious to one of ordinary skill in the art to modify electrical energy of a charge ranging from 0.2 nanocoulombs and 5 kilocoulomb by routine experimentation to optimize the stimulation treatment. Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Concerning claim 63 and wherein applying electrical energy comprises applying electrical energy directly, transdermally applying electrical energy, or percutaneously applying electrical energy (see para [0040]).
Concerning claim 64 and applying energy comprises applying energy with energy steering (see para [0044]-[0046]).
Concerning claim 65 and applying electrical energy comprises applying to one or more of: the vagus nerve, the splenic nerve, the femoral nerve or the sacral nerve (see para [0027]).
Concerning claim 66 and applying electrical energy comprises applying to one or more of the vagus nerve and the splenic nerve, or a nerve that drive activation of the vagus nerve or splenic nerve (see para [0027]).
Concerning claim 67 and applying electrical energy comprises applying to one or more nerve ending within an organ in one or more of: the spleen, the liver, the lymph nodes, the stomach, the small bowel, the large intestine, the pancreas, and the thymus (see para [0028]).
Concerning claim 68 and the TNF inhibitor therapy is one or more of: etanercept, adalimumab, certolizumab pegol, infliximab, golimumab, and biosimilars thereof (see TABLE 2).
Concerning claim 69 and the patient has an immune or inflammatory disorder (see para [0006]).
Concerning claim 70 and the immune or inflammatory disorder is one of: rheumatoid arthritis, bursitis, gouty arthritis, polymyalgia rheumatica, Crohn's disease, ulcerative colitis, multiple sclerosis, coeliac disease, systemic lupus erythematosus, aplastic anemia, myocarditis, spondyloarthritis, inflammatory myositis, alopecia, psoriasis, hay fever, atherosclerosis, asthma, chronic inflammation, chronic prostatitis, glomerulonephritis, nephritis, pelvic inflammatory disease, reperfusion injury, transplant rejection, and vasculitis (see para [0052]).
Concerning claim 71 and applying electrical energy comprises applying a plurality of electrical stimulations each having a current no greater than an upper comfort level (see para [0046]).
Concerning claim 74 and applying electrical energy comprises applying nerve stimulations of less than 50 mA.
Concerning wherein applying electrical energy comprises applying a charge nerve stimulations of less than 50 mA.. TRACEY teaches the method, wherein applying electrical energy comprises applying nerve stimulations {abstract; para [0008]), but does not explicitly teach wherein applying electrical energy comprises applying a charge nerve stimulations of less than 50 mA.. However, ii would have been obvious to one of ordinary skill in the art to modify electrical energy of a charge nerve stimulations of less than 50 mA. by routine experimentation to optimize the stimulation treatment. Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Concerning claim 75 and wherein applying electrical energy comprises applying nerve stimulations of less than 2 mA.
Concerning wherein applying electrical energy comprises applying a charge nerve stimulations of less than 2 mA.. TRACEY teaches the method, wherein applying electrical energy comprises applying nerve stimulations {abstract; para [0008]), but does not explicitly teach wherein applying electrical energy comprises applying a charge nerve stimulations of less than 2 mA.. However, ii would have been obvious to one of ordinary skill in the art to modify electrical energy of a charge nerve stimulations of less than 2mA. by routine experimentation to optimize the stimulation treatment. Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Concerning claim 76 and applying electrical energy comprises applying nerve stimulations ranging from 20pA to 200 pA. TRACEY teaches the method, wherein applying electrical energy comprises applying nerve stimulations {abstract; para [0008]), but does not explicitly teach wherein applying electrical energy comprises applying a charge nerve stimulations ranging from 20pA to 200 pA.. However, ii would have been obvious to one of ordinary skill in the art to modify electrical energy of a charge nerve stimulations ranging from 20pA to 200 pA. by routine experimentation to optimize the stimulation treatment. Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Concerning claim 77 and applying electrical energy comprises applying nerve stimulations ranging from 200pA and 3 mA. TRACEY teaches the method, wherein applying electrical energy comprises applying nerve stimulations {abstract; para [0008]), but does not explicitly teach wherein applying electrical energy comprises applying a charge nerve stimulations ranging from 200pA and 3 mA... However, ii would have been obvious to one of ordinary skill in the art to modify electrical energy of a charge nerve stimulations ranging from 200pA and 3 mA.. by routine experimentation to optimize the stimulation treatment. Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Concerning claim 78 and applying electrical energy comprises applying electrical energy from an implanted device (see para [0046]).
Concerning claim 81 and the at least one electrode comprises a linear array of electrodes or a nonlinear array of electrodes (see para [0046]).
Concerning claim 82 and the implanted device is a leadless device comprising a pulse generator and at least one electrode integrated onto the implanted pulse generator (see para [0046]).
Concerning claim 83 and the implanted device is a transcutaneously powered leaded devices with a receiver that receives, stores, and/or transforms energy delivered from outside the body (see para [0063]).
Concerning claim 84 and the receiver receives electrical transmission, including nearfield, midfield, and far field transmissions at amplitudes between 0.1 uA- 500 mA. TRACEY teaches the method, wherein applying electrical energy comprises applying nerve stimulations {abstract; para [0008]), but does not explicitly teach wherein electrical transmission, including nearfield, midfield, and far field transmissions at amplitudes between 0.1 uA- 500 mA... However, ii would have been obvious to one of ordinary skill in the art to modify electrical energy electrical transmission, including nearfield, midfield, and far field transmissions at amplitudes between 0.1 uA- 500 mA. by routine experimentation to optimize the stimulation treatment. Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Concerning claim 85 and administering, concurrent with the application of electrical energy, the same drug, or a drug of the same class that inhibits TNF that the patient had previously failed to respond to (see para [0064] and Table 2).
Concerning claim 86 Tracey discloses a method of reducing inflammation in a patient that is intolerant to or has failed to respond to either TNF inhibition, the method comprising:identifying that the patient has failed to respond to TNF inhibitor therapy comprising a drug that inhibits TNF; administering a treatment regimen to activate a neuroimmune anti-inflammatory pathway in the patient by applying energy to one of: a vagus nerve, a splenic nerve, a radial nerve, a median nerve, an ulnar nerve, a femoral nerve, a sciatic nerve, a tibial nerve, a splanchnic nerve, a phrenic nerve, a hepatic nerve, a renal nerve, a greater auricular nerve, a lesser occipital nerve, or an auriculotemporal nerve; and administering, concurrent with the application of energy, the same drug, or a drug of the same class that inhibits TNF that the patient had previously failed to respond to. (see abstract, and para [0008], [0046], [0015], [0064] and rejection of claim 62 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
