DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 07/31/2025 has been entered. Claims 4 and 8 are cancelled. Claims 17 and 18 are new. Claims 1-3, 5-7, and 9-18 are pending in this application. Claims 5-7 and 9-16 are withdrawn. Claims 1-3, 17, and 18 are currently under examination.
Priority
This application is a 371 of PCT/IB2020/058009 fled on 08/27/2020 and claims foreign priority of ITALY 102019000015192 filed on 08/29/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) with appropriate assertion under 37 CFR 1.98 filed on 08/01/2025 has been considered.
Withdrawn Claim Objection/Rejections
The objection of claims 1-4, as set forth on pages 3 to 4 of the Non-Final Rejection mailed on 04/01/2025, is withdrawn in view of amended claims 1-3 and cancelled claim 4.
The rejection of claims 3 and 4 under 35 U.S.C. 112(b), as set forth on page 4 of the Non-Final Rejection mailed on 04/01/2025, is withdrawn in view of amended claim 3 and cancelled claim 4.
The rejection of claims 1-4 under 35 U.S.C. 102(a)(1) as being anticipated by Gennari, as set forth on page 5 of the Non-Final Rejection mailed on 04/01/2025, is withdrawn in view of amended claims 1-3 and cancelled claim 4.
The rejection of claims 1-3 under 35 U.S.C. 102(a)(1) as being anticipated by Shukla et al., as set forth on page 5 of the Non-Final Rejection mailed on 04/01/2025, is withdrawn in view of amended claims 1-3.
New (necessitated by amendment) Claim Objections
Claims 2, 3, and 18 are objected to because of the following informalities: In claims 2 and 3, delete the inconsistent and redundant recitation “comprising the step of using arginine as a stabilizer of S-Adenosyl-l-methionine or a salt thereof in an edible orosoluble formulation” (lines 1-3 of claims 2 and 3) to tie with the preamble of the preceding claim 1; also in claim 2, change the incorrect recitation characterized in that” (line 4) to “wherein” to become a proper dependent claim. In claim 18, insert the comma “,” immediately before the recitation “wherein” (line 1) to be consistent with other dependent claims. Appropriate correction is required.
Claim 17 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New (necessitated by amendment) Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: The recitations “diluents”, “lubricants”, “aggregating agents”, “disintegrating agents”, “film forming agents”, “coloring agents”, “sweeteners or flavoring agents” and “antioxidants-antimicrobials” are not specifically defined and thus overlap in scope. The conjunction “and” would duplicate the same excipient or result in broad plus narrow limitations. Applicant is advised to change the conjunction “and/or” (last line) to “or”.
New (necessitated by amendment) 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.
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.
(I) Claims 1-3, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Gennari (US 5,114,931, published on March 19, 1992, hereinafter referred to as Gennari ‘931, also listed in IDS filed on 02/24/2022) incorporated by Fiecchi (US4,057,686, Nov. 8, 1977, hereinafter referred to as Fiecchi ‘686).
With regard to structural limitation “a method comprising the step of mixing arginine (or L-arginine) and S-Adenosyl-L-methionine or a salt (or tosylate) thereof to form an orosoluble (defined as “the term "orosoluble" refers to compositions capable of dissolving and releasing immediately the active ingredient contained therein when contacted with the oral mucosa”, in the specification) formulation, and at least one physiologically acceptable excipient (or diluents)” (claims 1-3, 17, and 18):
Gennari ‘931 disclosed a stable S-adenosyl-L-methionine (hereinafter referred to as SAMe) salts in an aqueous solution which is adjusted to a pH of between 5 and 8.5 and contains an amino acid and an alkaline base. EXAMPLE4:
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(col. 2, lines 15-18; col. 4, lines 47-60). This together with numerous other patents U.S. Pat. Nos. 3,893,999, 3,954,726 and 4,057,686, and European patent application 82107333.5) relating to thermally stable SAMe salts and the industrial processes for their preparation are commonly assigned (col. 1, lines 47-52). Fiecchi ‘686 (incorporated by reference as cited by Gennari ‘931) disclosed a process of using 3.3g of a 15% solution of p-toluensulphonic acid in methanol, the subsequent precipitation stage with 25 ml of ethyl ether gives 1.18 g of the salt SAM+.HSO4-.2 CH3C6H4SO3H, which has the same characteristics as those indicated for the product of Example 1. In all cases SAM proved active both administered orally (dose between 8 and 40 mg/kg) and parenterally (doses between 4 and 8 mg/kg) in comparison with other known drugs (col. 14, lines 31-37; col., 21, lines 30-34).
Thus, these teachings of Gennari ‘931 incorporated by Fiecchi ‘686 anticipate Applicant’s claims 1-3, 17, and 18 because the acidic SAMe di-sulphate-di-p.toluenesulphonate is equivalent to “SAMe tosylate” in the Specification of this Application and oral formulation is also active as the parenteral composition, described above, and would achieve the required “orosoluble formulation”. Or, in an alternative, skilled artisan would be motivated to prepare an oral formulation of SAMe or salt thereof.
(II) Claims 1-3, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giovannone et al. (WO 2015/071806, May 21, 2015, hereinafter referred to as Giovannone ‘806).
With regard to structural limitation “a method comprising the step of mixing arginine (or L-arginine) and S-Adenosyl-L-methionine or a salt (or tosylate) thereof to form an orosoluble (defined as “the term "orosoluble" refers to compositions capable of dissolving and releasing immediately the active ingredient contained therein when contacted with the oral mucosa”, in the specification) formulation, and at least one physiologically acceptable excipient (or diluents or film forming agents)” (claims 1-3, 17, and 18):
Giovannone ‘806 disclosed a composition consists of: a) a core containing a donor of methyl groups and at least one pharmaceutically acceptable excipient, and b) an outer coating containing shellac and/or a pharmaceutically acceptable salt thereof, magnesium stearate, and at least one pharmaceutically acceptable excipient. A donor of methyl groups is preferably selected from S-adenosyl-L-methionine (SAMe). Preferably said pharmaceutically acceptable salt of SAMe is selected from sulfate p-toluensulfonate (= tosylate) or 1,4-butanedisulfonate. Said coating comprises shellac or a pharmaceutically acceptable salt thereof. More preferably said shellac salt is arginine salt. The solid oral composition is characterized in that no more than 10% of the donor of methyl groups is released in the first two hours and the remaining 90% is released in the following nine hours, according to a zero order kinetic release. Extensive evidence shows how SAMe is actually absorbed in different sectors of the gastrointestinal tract, at different levels of efficiency, including the buccal mucosa (page 6/49, para. 3; page 7/49, para. 1 and 5; page 8/49, para. 5; page 9/49, para. 6; page 4/49, para. 4). Example 1, Tablets containing 400 mg SAMe sulfate p-toluensulfonate/tablet, prepared by mixing, pre-compression, granulation, mixing, compression, and Tablet filming (pages 13/49 to 15/49).
Thus, these teachings of Giovannone ‘806 anticipate Applicant’s claims 1-3, 17, and 18.
Conclusion
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 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.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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