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 03/10/2025 has been entered. Claims 1-16 are pending in this application. Claims 5-16 are withdrawn. Claims 1-4 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.
Election/Restrictions
Applicant's election with traverse of Group I invention (claims 1-4) and species (S-Adenosyl-l-methionine) in the reply filed on 04/08/2019 is acknowledged. The traversal is on the ground(s) that “Applicant has now amended claims 1-4 to be a method of preparing a formulation having the prior limitations of each claim… the combination of the product (claims 5-16) and a process specially adapted for the manufacture of the product is set forth at category (1) as having unity of invention” (p. 1, lines 3-5 and 9-11). This is not found persuasive because "Groups I/II are directed to a technical feature: an acid active ingredient having a pKa of between 1 and 5 (e.g. S-adenosyl-L-methionine) and arginine. This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Gennari”, as set forth no page 4 of the Restriction/Election Requirement mailed on 01/10/2025. “Lack of unity of invention may be directly evident “ a priori ,” that is, before considering the claims in relation to any prior art, or may only become apparent “ a posteriori ,” that is, after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.“ (see MPEP § 1850 [R-01.2024], 37 CFR 1.475, II).
Claims 5-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1-4 are currently under examination. The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/24/2022 has been considered.
Claim Objections
Claims 1-4 are objected to because of the following informalities: In claim 1, change the incorrect recitation “of using” (line 1) and “of an acid active” (line 2) to “of mixing” and “and an acid active”, because the claim is directed to a method of preparing and requires both arginine and an acid active. In claims 2 and 4, delete the incorrect and excessive recitation “comprising the step of using arginine and/or a pharmaceutically acceptable salt thereof” (lines 1 to 2 of claims 2 and 4); change the incorrect dependent claim format “, characterized in that said” (lines 2 to 3 of claims 2 and 4) to “, wherein said”; and also in claim 2, insert the missing phrase “the group consisting of” immediately after the recitation “selected from” (line 3 of claim 2) to be consistent with Markush group format ending with the conjunction “and” before the last species. In claim 3, delete the incorrect and excessive recitation “comprising the step of using arginine and/or a pharmaceutically acceptable salt thereof” (lines 1 to 2), change the recitation “of claim 1” (line 2) to “according to claim 1” to be consistent with preceding claim; replace the incorrect dependent claim format “, characterized in that said” (lines 2 to 3) with “, wherein said”; and insert the missing phrase “the group consisting of” immediately after the recitation “selected from” (line 3) to be consistent with Markush group format ending with the conjunction “and” before the last species. Appropriate correction is required.
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.
Claims 3 and 4 are 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 pre-AIA the applicant regards as the invention. Claim 4 depends from claim 3.
Regarding claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant is advised to delete the recitations “such as” (line 4) and “, such as extracts of acerola and dog rose” (line 6).
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.
(I) Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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).
With regard to structural limitation “a method comprising the step of mixing arginine (or L-arginine) and an acid active ingredient having a pKa of between 1 and 5 (or S-Adenosyl-L-methionine or a salt thereof)” (claims 1-4):
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).
Thus, these teachings of Gennari ‘931 anticipate Applicant’s claims 1-4 because the acidic SAMe di-sulphate-di-p.toluenesulphonate is equivalent to “SAM-e tosylate” in the Specification of this Application and meets the limitation of an acid active ingredient having a pKa of between 1 and 5.
(II) Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shukla et al. (J. Phys. Chem. B 115:11831–11839, 2011, hereinafter referred to as Shukla ‘2011).
With regard to structural limitation “a method comprising the step of mixing arginine (or L-arginine) and an acid active ingredient having a pKa of between 1 and 5 (or glutamic acid)” (claims 1-3):
Shukla ‘2011 disclosed that simultaneous addition of L-arginine hydrochloride and L-glutamic acid enhances the maximum achievable solubility of several poorly soluble proteins. The protein solubility enhancement is related to the relative increase in the number of arginine and glutamic acid molecules around the protein in the equimolar mixtures due to additional hydrogen bonding interactions between the excipients on the surface of the protein when both excipients are present. These results highlight the role of additive-additive interaction in tuning the protein-protein interactions. The pKa value for the side chain group in the glutamic acid is 4.1 (page 11831, Abstract; page 11832, right col., para. 1).
Thus, these teachings of Shukla ‘2011 anticipate Applicant’s claims 1-3.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691