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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/20/26 has been entered.
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.
Claims 1-2, 4-5, 7-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Carmena el al. (US 2024/0100327), in view of Levine et al. (US 2024/0299745) and further in view of Carmena et al. (US 2019/0321640).
Addressing claims 1 and 7, Carmena discloses:
a method to treat an inflammatory disease state in a mammalian patient comprising applying focused ultrasound stimulation (FUS) to stimulate, wherein suppression of tumor necrosis factor (TNF) levels and elevation of interleukin-10 (IL-10) levels in a patient’s serum is indicative of an amount of FUS effective to treat the inflammatory disease state in a mammalian patient (see Fig. 14, [0010-0011], [0070] and [0176-0178]; measure the serum).
a method suppressing tumor necrosis factor (TNF) levels in a mammalian patient and increasing interleukin-10 (IL-10) levels in the mammalian patient comprising applying focused ultrasound stimulation (FUS) to the patient to stimulate, wherein suppression of tumor necrosis factor (TNF) levels and elevation of interleukin-10 (IL-10) levels in a patient’s serum is indicative of an amount of FUS effective to suppress TNF levels and increase IL-10 levels in a mammalian patient (see Fig. 14, [0010-0011], [0070] and [0176-0178]).
Carmena (US 2024/0100327) does not explicitly disclose non-invasive ultrasound treatment, the stimulation region is neuronal ending, neuronal bodies within celiac-superior mesenteric ganglion complex (CSMGC). This is just designer choice. Levine explicitly teach non-invasive ultrasound stimulation of nerve (see [0025]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Carmena (US 2024/0100327) to perform non-invasive ultrasound stimulation of nerve because non-invasive provide such benefit as quicker recovery.
In the same field of endeavor, Carmena (US 2019/0321640) discloses the stimulation region is neuronal ending, neuronal bodies within celiac-superior mesenteric ganglion complex (CSMGC) (see abstract and [0018]; celiac ganglion, superior mesenteric nerve). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Carmena (US 2024/0100327) to stimulate region is neuronal ending, neuronal bodies within celiac-superior mesenteric ganglion complex as taught by Carmena (US 2019/0321640) because any nerve such as vagus nerve, the celiac ganglion, the sub-diaphragmatic vagus nerve, a splanchnic nerve, splenic and/or a superior mesenteric nerve can be target to treat inflammation (see [0018]). Carmena (US 2019/0321640) provided variety of choice of target region.
Addressing claims 2, 4-5, 8 and 10-12, Carmena (US 2024/0100327) discloses:
Addressing claims 2 and 11, Carmena discloses wherein the inflammatory disease state is one or more of sepsis, endotoxemia, metabolic endotoxemia in obesity and type 2 diabetes, septicemia, septic shock, rheumatoid arthritis, Crohn’s disease, cancer, ankylosing spondylitis, cardiac ischemia, cerebral ischemia, vasculitis, Alzheimer’s disease, multiple sclerosis, systemic lupus erythematosus, obesity, asthma, diabetes, acute liver injury, non-alcoholic steatohepatitis, and liver disease. Carmena discloses (see [0008-0009] and [0036]; Carmena also discloses reduce/suppress TNF in serum after stimulation (see abstract; cancer).
Addressing claims 4 and 8, suppress TNF levels in the patient’s liver, (see Carmena (US 2019/0321640)’s paragraph [0004]; target vagus nerve, splenic nerve, celiac ganglion and superior mesenteric nerve effect the TNF levels in the patients’ liver).
Addressing claims 5 and 12, wherein the mammalian patient is a human (see [0027]).
Addressing claim 10, where in mammalian patient has an inflammatory disease state (see abstract; cancer).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Carmena el al. (US 2024/0100327), in view of Levine et al. (US 2024/0299745) and further in view of Carmena et al. (US 2019/0321640) and Gross (US 2015/0245867).
Addressing claim 6, Carmena (US 2024/0100327) does not disclose wherein the inflammatory disease state is endotoxemia, metabolic endotoxemia in obesity and type 2 diabetes, sepsis, and acute liver injury. Gross explicitly teaches inflammatory disease state is sepsis (see [0363]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rossato to have wherein the inflammatory disease state is sepsis as taught by Gross because this allows the technique to treating variety of inflammation disease state (see [0363]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-8 and 10-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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