DETAILED ACTION
This office action is in response to applicant’s filling dated June 10, 2024.
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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of implied phrases and legal phraseology employed in line 1 stating “provided herein are …” and the improper placement of the title in the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
In addition, MPEP § 606 states that the title of the invention should be placed at the top of the first page of the specification unless it is provided in the application data sheet. This is on a separate sheet than the abstract as indicated by MPEP § 608.1c which states that the abstract must commence on a separate sheet, preferably following the claims, under the heading "Abstract" or "Abstract of the Disclosure." The sheet or sheets presenting the abstract may not include other parts of the application or other material.
As such, the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5, 7-9, 12, 19-21, 23-30, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chae et al. (US 20200368186).
Regarding claims 1, 8, 19-21, 23-25, and 35, Chae et al. teaches of a method of modulating metabolism comprising administering to as subject in need thereof a consumable composition comprising at least one carrier and an effective amount of an extract comprising a compound of formula I:
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where R1 is present or absent, and when present is a substituent on one or more ring atoms and is for each ring atom independently a hydroxy group, substituted or unsubstituted lower alkyl group, halo group, substituted or unsubstituted lower alkyl group, or substituted or unsubstituted lower alkoxy group; the dashed bond is present or absent; and N-trans caffeoyltyramine is a recited embodiment (pp. 24, paragraph 9, claim 1 – pp. 25, paragraph 5, claim 8). Chae also exemplifies that compounds such as N-trans caffeoyltyramine can help mitigate and address fatty liver disease, which is characterized by inflammation (pp. 1, abstract, pp. 18, paragraph 2). Chae claims the use of the composition to treat metabolic disorders comprising obesity, where Chae defines obesity as having a BMI of 30 or higher (pp. 25, paragraph 4, claim 7; pp. 17, paragraph 6). Chae also exemplifies that the N-trans caffeoyltyramine may be formulated for oral consumption as a dietary supplement, food ingredient or additive, medical food, nutraceutical, pharmaceutical composition, or liquid formulation for oral administration to humans and other animals (pp. 15 paragraph 7 – pp. 18 paragraph 8). Chae also details a mouse model study of N-trans-caffeoyltyramine on diet induced obese mice where the mice were given a high fat diet prior to the trials (pp. 21, paragraph 8). The obese mice were then treated with 120 mg per kg of N-trans-caffeoyltyramine twice a day for 2 weeks which lowered liver fat accumulation (pp. 21, paragraph 8 – pp. 22, paragraph 2).
Thus, Chae anticipates the method of claims 1, 8, 19-21, 23-25, and 35.
Regarding claims 2 and 12, Chae teaches the use of the composition to treat metabolic disorders comprising obesity and type II diabetes (pp. 25, paragraph 4, claim 7). Chae also exemplifies that compounds such as N-trans caffeoyltyramine can help mitigate and address metabolic disorders such as nonalcoholic fatty liver disease or nonalcoholic steatohepatitis (pp. 1, abstract and examples).
Thus, Chae anticipates the method of claims 2 and 12.
Regarding claims 5, 7, 9, and 26-30, prior art is silent regarding "increasing fatty acid oxidation (FAO) activity in the subject," “reducing mitochondrial stress in the subject,” “decreasing level of IL-6, TNFa, or nitric oxide in the subject,” “reducing the body weight of the subject by at least about 10%, 20%, 30%, 40%, or 50%, or reduced an amount by weight % within a range defined by any of the preceding values, as compared to a reference subject having a similar body weight and the same diet but is not administered N-trans caffeoyltyramine, or a pharmaceutically acceptable salt thereof,” and “increasing the mitochondrial mass and/or function in the subject” “wherein the mitochondrial mass/or function is measured by the expression level of cytochrome C or succinate dehydrogenase (SDHA)” “wherein the mitochondrial mass and/or function is increased in the subject’s liver” “wherein the mitochondrial mass and/or function is increased in primary hepatocytes of the subject.” However: "increasing fatty acid oxidation (FAO) activity in the subject," “reducing mitochondrial stress in the subject,” “decreasing level of IL-6, TNFa, or nitric oxide in the subject,” “reducing the body weight of the subject by at least about 10%, 20%, 30%, 40%, or 50%, or reduced an amount by weight % within a range defined by any of the preceding values, as compared to a reference subject having a similar body weight and the same diet but is not administered N-trans caffeoyltyramine, or a pharmaceutically acceptable salt thereof,” and “increasing the mitochondrial mass and/or function in the subject” “wherein the mitochondrial mass/or function is measured by the expression level of cytochrome C or succinate dehydrogenase (SDHA)” “wherein the mitochondrial mass and/or function is increased in the subject’s liver” “wherein the mitochondrial mass and/or function is increased in primary hepatocytes of the subject” will naturally flow from the teachings of the prior art (see above rejection), since the same method (administering N- trans caffeoyltyramine, or a pharmaceutically acceptable salt thereof, to the subject in an amount of 30 mg per kg per day to about 400 mg per kg per day for a period of time) is being administered to the same subjects.
In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding "increasing fatty acid oxidation (FAO) activity in the subject," “reducing mitochondrial stress in the subject,” “decreasing level of IL-6, TNFa, or nitric oxide in the subject,” “reducing the body weight of the subject by at least about 10%, 20%, 30%, 40%, or 50%, or reduced an amount by weight % within a range defined by any of the preceding values, as compared to a reference subject having a similar body weight and the same diet but is not administered N-trans caffeoyltyramine, or a pharmaceutically acceptable salt thereof,” and “increasing the mitochondrial mass and/or function in the subject” “wherein the mitochondrial mass/or function is measured by the expression level of cytochrome C or succinate dehydrogenase (SDHA)” “wherein the mitochondrial mass and/or function is increased in the subject’s liver” “wherein the mitochondrial mass and/or function is increased in primary hepatocytes of the subject”, by practicing the method made obvious by the prior art: "administering N- trans caffeoyltyramine, or a pharmaceutically acceptable salt thereof, to the subject in an amount of 30 mg per kg per day to about 400 mg per kg per day for a period of time", one will also be "increasing fatty acid oxidation (FAO) activity in the subject," “reducing mitochondrial stress in the subject,” “decreasing level of IL-6, TNFa, or nitric oxide in the subject,” “reducing the body weight of the subject by at least about 10%, 20%, 30%, 40%, or 50%, or reduced an amount by weight % within a range defined by any of the preceding values, as compared to a reference subject having a similar body weight and the same diet but is not administered N-trans caffeoyltyramine, or a pharmaceutically acceptable salt thereof,” and “increasing the mitochondrial mass and/or function in the subject” “wherein the mitochondrial mass/or function is measured by the expression level of cytochrome C or succinate dehydrogenase (SDHA)” “wherein the mitochondrial mass and/or function is increased in the subject’s liver” “wherein the mitochondrial mass and/or function is increased in primary hepatocytes of the subject,” even though the prior art was not aware of it.
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Thus, Chae anticipates the method of claims 5, 7, 9, and 26-30.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 2, 5, 7-9, 12, 19-21, 23-30, 32, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Chae et al. (US 20200368186) in view of Zhu et al (U, Zhu, Y. et al. “System Biology Analysis Reveals the Role of Voltage-Dependent Anion Channel in Mitochondrial Dysfunction During Non-Alcoholic Fatty Liver Disease Progression into Hepatocellular Carcinoma.” Cancer Science, Vol 11, 4288-4302).
The teachings of Chae are set forth above and applied as before.
Chae does not expressly teach that the method further comprises measuring the expression level of VDAC1, citrate synthase, sirtuin, or PGC1alpha.
However, Zhu et al. teaches that the VDAC1 gene is associated with mitochondrial dysfunction and the suggests that the expression of VDAC1 was strongly associated with the progression of various liver disease (pp. 4288, abstract).
It would have been obvious to one of ordinary skill in the art before the effective filling date to utilize the method taught by Chae to reduce the body weight of a subject by administering N-trans caffeoyltyramine and to measure VDAC1 expression levels. One would be motivated by Zhu, who states that VDAC1 expression levels are strongly associated with the progression of various liver diseases. As such, one of ordinary skill in the art at the time of the invention would have had a reasonable expectation of success to measure the VDAC1 expression levels to determine if the patient has healthy or improving liver function after treatment with N-trans caffeoyltyramine.
Conclusion
Claims 1, 2, 5, 7-9, 12, 19-21, 23-30, 32, and 35 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON RAFANAN ULLMAN whose telephone number is (571)272-6623. The examiner can normally be reached 7:30 am to 5:00 pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON RAFANAN ULLMAN/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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