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 .
Status of Claims
Claims 1-16 are pending as of the response and amendments filed on 12/18/25.
The amendment to the specification to remove the reference to an embedded hyperlink is acknowledged and accepted. The objection to the specification is withdrawn.
The rejection under 35 USC 112(b) is withdrawn in view of the amendments.
Applicants have traversed the 102(a)(1) rejection over Mardinoglu, which is addressed below.
Applicants have argued while Mardinoglu mentions other disorders, the experimental data provided in the publication focuses exclusively on hepatic steatosis and lipid metabolism, not glucose intolerance. Applicants have referred to the study of six patients with fatty liver, serine supplementation reduced liver fat, ALT/AST levels, and triglycerides, but no significant improvements were observed in fasting glucose, fasting insulin, or HOMA-IR (Table 3 of Mardinoglu).
Applicants’ arguments are not persuasive. Mardinoglu is drawn to a method of treating a medical condition “selected from the group consisting of non-alcoholic fatty liver disease (NAFLD), alcoholic fatty liver disease (AFLD), type 2 diabetes, obesity, insulin resistance and dyslipidemia” (abstract; p. 18, lines 11-14). Therefore, Mardinoglu clearly includes type 2 diabetes and insulin resistance as conditions to be treated. Moreover, Mardinoglu states “HS is the characteristic feature of non-alcoholic fatty liver disease (NAFLD) and it is strongly associated with obesity, insulin resistance, type 2 diabetes (T2D) and cardiovascular diseases” (p. 1, lines 9-12). Regarding Table 3, the data as provided in this table was obtained from patients with fatty liver, as noted by Applicants. Additionally, Applicants’ claims are not drawn to reducing fasting glucose or fasting insulin levels, but rather to treating/preventing glucose intolerance “and/or one or more diseases associated with glucose intolerance”. As Mardinoglu includes HS as a disease associated with glucose intolerance, and Applicants’ claims include treatment of diseases associated with glucose intolerance, the disclosure of Mardinoglu clearly reads on Applicants’ claims. Applicants’ specification also defines “treat” and “treatment” to refer to the administration or consumption of O-acetylserine or a salt or derivative thereof for the purpose of curing, alleviating, reducing, attenuating, or amelioration of a disease or pathological disorder, or one or more associated symptoms (p. 11, lines 11-19), and as such “treating” glucose intolerance and/or one or more diseases associated with glucose intolerance isn’t limited to reducing fasting glucose or fasting insulin levels.
Applicants have further argued only serine is tested in Mardinoglu, and neither OAS or any of its derivatives, including NAS, have actually been tested. Applicants have also stated serine and its acetylated analogs present different structures and therefore different functions, and one skilled in the art would not consider extrapolating the actions demonstrated for serine on HS to its acetylated analogs without further information than that provided in Mardinoglu.
Applicants’ arguments are not persuasive. Regarding the experimental data shown in Mardinoglu, a prior art reference is relied upon for all that it teaches, not just experimental data or examples; see MPEP 2123. Additionally, while Applicants have noted the differences in structure and function among acetylated analogs of serine, it is noted Applicants’ claims are drawn to administering O-acetylserine as well as any derivative thereof. The examiner maintains that N-acetylserine, which is included in Applicants’ specification as a derivative of O-acetylserine, is disclosed throughout Mardinoglu for treating a medical condition “selected from the group consisting of non-alcoholic fatty liver disease (NAFLD), alcoholic fatty liver disease (AFLD), type 2 diabetes, obesity, insulin resistance and dyslipidemia” (see p. 1, lines 9-19; p. 10, claim 22; p. 20, lines 5-27). As Mardinoglu clearly states N-acetylserine as an active agent in the therapeutic composition which further includes a small, defined list of other agents, the 102(a)(1) rejection over Mardinoglu is maintained.
Claims 1-16 were examined. Claims 1-3, 5-7, 9-10, and 15-16 are rejected. Claims 4, 8, and 11-14 are objected to.
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)(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.
Claim(s) 1-3, 5-7, 9-10, and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mardinoglu et. al., WO 2018117954 A1, publ. 6/28/2018.
Mardinoglu discloses treatment of fatty liver related conditions by administering a composition comprising a combination of active agents (title & abstract). More particularly, Mardinoglu discloses treatment of a medical condition selected from non-alcoholic fatty liver disease (NAFLD), alcoholic fatty liver disease, type 2 diabetes or obesity comprising orally administering to a subject in need thereof a composition comprising: A) serine, glycine, betaine, N-acetylglycine, N-acetylserine, dimethylglycine, sarcosine, and/or phosphoserine; B) optionally N-acetyl cysteine, cysteine, and/or cystine; and C) optionally carnitine, deoxycarnitine, gamma-butyrobetaine, 4-trimethylammoniobutanal, 3-hydroxy-N6,N6,N6-trimethyl-L-lysine, N6,N6,N6-trimethyl-L-lysine, and/or lysine; and D) nicotinamide riboside, quinolinate, diamino-NAD+, nicotinate D-ribonucleotide, nicotinamide D-ribonucleotide, nicotinate D-ribonucleoside, nicotinamide and/or nicotinate (p. 20, lines 5-27; p. 49, claim 17). Applicants’ specification defines derivatives of O-acetylserine to include N-acetylserine (p. 10, lines 7-22). Therefore, one of ordinary skill in the art would have immediately envisaged treating type 2 diabetes and obesity in a subject in need thereof comprising administering a composition comprising N-acetylserine, in combination with the actives described above. Mardinoglu further discloses the composition in the form of a solution or suspension (pp. 47-48, claims 1 and 9); therefore, it would have been expected the composition would have contained a pharmaceutically acceptable vehicle. Mardinoglu therefore anticipates the claims, based on the disclosure of administering a pharmaceutical composition comprising N-acetylserine in combination with other actives for the treatment of type 2 diabetes and obesity, as N-acetylserine is encompassed by the instant claims as a derivative of O-acetylserine.
Claim Objections
Claims 4, 8, and 11-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim, i.e., requiring the compound being administered to be limited to O-acetylserine and excluding “or derivative thereof”, and any intervening claims.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627