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 .
Response to Argument and Amendment
The response filed on 10/27/25 has been entered.
Applicant’s arguments filed 10/27/25 have been fully considered but they are not deemed to be persuasive.
Claims 1-3, 8-12 are pending in this office action. Claims 15-16, 30-31, 37, 47, 54-55 and 57 are currently withdrawn.
Claim Objections
Claim 56 is objected to because of the following informalities: the claim is incomplete. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-2, 8, 10 -12 is/are stand rejected under 35 U.S.C. 102(a2) as being anticipated by Fantuzzi (US 2008/0226710)
With regards to instant claim 1, Fantuzzi teaches a composition comprises L-carnitine combined with CoQ-0 (see 0038) and a fatty acid (see 0034) wherein the fatty acid is a short chain as further limited by claim 8 and 10 is a butyric acid (see 0034) and the carnitine is a propionylcarnitine (as required by instant claims 2 and 10, see 0043) in a suitable excipient (as required by instant claim 12, see 0070) and therefore anticipated to be non-additive, since the reference teaches the elements in the composition. As such, the claimed limitations appears to be met by the prior art. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on the applicant to prove that the function of the product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Applicant argues that the amendment for “treating an addiction disorder” would overcome the rejection.
In response, this is found unpersuasive because, it should be noted that “a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone”. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)
Modified 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.
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.
Claim(s) 1-3 and 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi (US 2008/0226710) in view of Sinatra (2010 HeartMD Institute) and He et al. (Pharmacological Research 144 (2019)116-131) in view of Bykov et al. (Alcohol and alcoholism, 38(5) 2003 400-406)
. Fantuzzi is applied here as above. However fails to teach that the carnitine comprises about 400 mg/day to 4000 mg and the fatty acid comprises 500-4000 mg/day as required by instant claims 3 and 9. Nonetheless, the dosageamount of a pharmaceutical composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal dosage amount of the active ingredient in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage amount would have been obvious at the time of applicant's invention.
Sinatra teaches administering L-carnitine to prevent deficiency from 400-800 mg/day.
He teaches administering from 200 mg/kg/day for lipid regulation wherein the dosage amount administered decreases liver steatosis.
Bykov et al. teach L-carnitine alleviates alcohol induced liver damage. Thus alcohol induced liver damage is due to alcohol addiction. Therefore it is reasonable to treat alcohol addiction with a L-carnitine.
It would have been obvious to one of ordinary skill in the art to expand the teachings of Fantuzzi to include both He and Sinatra and formulate a composition comprising carnitine and a short chain fatty acid with the provided dosage taught by he and Sinatra to result in the claimed invention with a reasonable expectation of success in preventing deficiency such as lipid regulation. It would have been obvious to one of ordinary skill in the art to have used the dosage in the composition because these dosages have been used before as taught by He and Sinatra.
Applicant argues that Fantuzzi does not disclose a composition and method for treating an addiction disorder. Fantuzzi's deficiency is not cured by neither Sinatra nor He. Sinatra is cited for the disclosure of the amount of 400-800 mg/day of L-carnitine to prevent deficiency; and He is cited for the disclosure of 200 mg/kg/day for lipid regulation and none of these references, alone or in combination, teach or suggest the claimed composition for treating an addiction disorder.
In response, Applicant’s argument is found unpersuasive for the following reasons: With regards to He, the dosage amount administered decreases liver steatosis. Liver steatosis is a fatty disease often due to alcohol consumption, therefore one of ordinary skill in the art would administer butyric acid to treat alcoholism an addition.
The rejection has been modified as necessitated by amendment.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 11/12/25
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