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, 3-12, and 14-26 are pending as of the response and amendments filed on 12/11/25.
Claims 2 and 13 have been canceled, claims 21-26 have been newly added.
The rejection under 35 USC 112(b) is withdrawn in view of the amendments.
The rejection under 35 USC 102(a)(1) over Gaetani is withdrawn in view of the amendments.
Claims 5-7, 11, and 17-18 were previously rejected under 103 as being unpatentable over Gaetani. Applicants’ reasons for traversal are summarized and addressed below.
Applicants have argued Gaetani relates to combination compositions for the “treatment of corneal diseases”, and further discusses corneal diseases to be selected from numerous diseases, but doesn’t disclose autoimmune diseases, let alone Sjogren’s syndrome. Applicants have further stated Gaetani describes one example where patients were treated twice daily with the combination composition comprising acetyl L-carnitine mucate 100 mg, fish oil 500 mg, and Coenzyme Q 10 mg., with L-carnitine taught to be most preferably at a dose of 0.1 g. Applicants have argued Gaetani fails to provide any guidance or discussion on which specific components within its combination compositions are responsible for the “treatment of corneal diseases”, and in particular fails to teach or suggest methods of treating Sjogren’s syndrome comprising administering greater than 500 mg. of a compound of Formula (II) or levocarnitine.
Applicants’ arguments are not persuasive. Gaetani discloses in the clinical trial patients treated with the composition were those suffering from Sjogren’s syndrome and dry eye (pp. 11-12, Ex. 1). Although Applicants’ arguments appear to imply that Gaetani teaches a combination composition Applicants’ claims have comprising language present and as such don’t exclude the presence of additional agents along with a compound of Formula (II). Moreover, while Gaetani teaches L-carnitine taught to be most preferably at a dose of 0.1 g, Gaetani also clearly teaches a preferred dose between 0.1-4.0 g. for L-carnitine or an alkanoyl L-carnitine, which includes the dose of greater than about 500 mg. recited in claims 12 and 14. It is maintained that the claimed method would have been prima facie obvious to one of ordinary skill in the art based on the guidance provided by Gaetani. The rejection is maintained and updated below based on amendments.
Claims 1, 3-12, and 14-26 were examined. Claims 12, 14, 17-20, and 23-26 are rejected. Claims 1, 3-11, and 21-22 are allowed. Claims 15-16 are objected to.
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) 12, 14, 17-20, and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaetani et. al., WO 2007006672 A1, of record.
Gaetani discloses the use of a medicament comprising L-carnitine and/or one or more alkanoyl L-carnitine derivatives, or pharmaceutically acceptable salts thereof for the treatment of corneal diseases (title & abstract; p. 1, lines 4-8). In particular Gaetani discloses treatment of female patients, including subjects suffering from Sjogren’s syndrome and having mild, moderate, or severe dry eye, by administering twice daily a composition comprising 100 mg. acetyl L-carnitine mucate, 500 mg. fish oil, and 10 mg. coenzyme Q for a period of 6 months (Ex. 1, p. 11, line 2-p. 12, all lines before Ex. 2). Therefore, Gaetani discloses treatment of a subject having Sjogren’s syndrome with symptoms of dry eye comprising administering a composition comprising 100 mg. acetyl L-carnitine mucate. Acetyl L-carnitine mucate is included in formula (II) of claim 12, wherein R =-C(O)-methyl. Gaetani further discloses the composition in any form suitable for oral administration to human subjects, e.g., systemically, with suitable excipients (p. 17, lines 12-21). Additionally, Gaetani teaches L-carnitine and/or an alkanoyl L-carnitine is preferably present in the composition in a dose of 0.1-4.0 g (p. 8, line 19-p. 9, line 21). As such, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated a patient with Sjogren’s syndrome and dry eye by administering a composition comprising L-carnitine and/or an alkanoyl L-carnitine in an amount from about 100 mg to 4000 mg., which overlaps with the dosage range recited in claims 12, 14, and 17-18, in view of the guidance provided by Gaetani, and have had a reasonable expectation of success. As Gaetani teaches in Ex. 1 the composition was administered twice daily to subjects with Sjogren’s syndrome and dry eye (Ex. 1, p. 11, line 2-p. 12, all lines before Ex. 2), it would have been prima facie obvious to have administered L-carnitine twice daily, wherein the composition comprises about 1000 mg. L-carnitine, and have had a reasonable expectation of success.
Claim Objections
Claims 15-16 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 and any intervening claims.
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 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