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 .
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “the poorly absorbable drug is GLP-1 agonist.” This is a minor informality because it GLP-1 does not have an article. Amending the claim to read “the poorly absorbable drug is a GLP-1 agonist” would be remedial.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Faggian et al. (Molecules, 2016, 21, 1531), as evidenced by Drug Bank (Lidocaine, 8/13/25 [retrieved 8/13/2025], retrieved from: https://go.drugbank.com/drugs/DB00281).
Faggian relates to the study of deep eutectic solvents as drug solubilization vehicles for active pharmaceutical ingredients [abstract]. “For this study, arginine (Ar) was selected as a HBA and it was coupled with 3 different HBDs: glutamic acid (Ga), oxalic acid (Oa) and tartaric acid (Ta). They were mixed in a 1 : 1 molar ratio to form DESs namely ArGa, ArOa and ArTa, Fig. 1. These 3 DESs were tested for [Lidocaine] solubility. Both experimental and theoretical methods were used and reported herein this manuscript” [p. 1062, right col., first para.]. In other words, Faggian discloses composition of Lidocaine in a solvent mixture of arginine and tartaric acid. Lidocaine is poorly absorbable through the skin (i.e., a biomembrane), as evidenced by Drug Bank at the first paragraph of the “Absorption” section on page 5. Therefore, Lidocaine is a poorly absorbable drug according to the instant specification, which states "’poorly absorbable drug’ includes a drug with poor biomembrane permeability” [instant specification, para. 0016].
The prior art anticipates instant claims 1 and 4 because it discloses a composition comprising a poorly absorbable drug (Lidocaine) in a solvent mixture of arginine and tartaric acid (ionic liquid).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
1) Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Towfly Bioscience Co Ltd (CN 102363633 A, publication date 02/29/2012; citing English machine translation; hereinafter “Towfly”).
Towfly discloses a composition comprising a glucagon like peptide-1 mutant polypeptide, a GLP-1 analogue, for the treatment of diabetes and obesity (i.e., GLP-1 agonist) [abstract]. The composition may comprise one or more pharmaceutically acceptable carries, including pH adjusting agents and stabilizers [p. 8, para. 3-4]. Suitable pH adjusting agents include citric acid, lactic acid and tartaric acid [p. 8, para. 7]. Suitable stabilizers include arginine and Tutofusin tris (i.e., CAS 77-86-1; trometamol) [p. 8, para. 10]. Towfly also discloses the composition may be formed as a liquid solution [p. 6, last para.].
The prior art is not anticipatory because it does not disclose all the claimed components in a single example or embodiment.
However, given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, at the time of filling, to have selected and combined known components for their established functions with predictable results by following the teachings of Towfly. See MPEP 2143 and 2144.06(I).
Therefore it, would have been obvious for one of ordinary skill in the art, at the time of filling, to have formulated a liquid composition comprising arginine or trometamol and citric acid, lactic acid or tartaric acid and a GLP-1 agonist. According to instant claim 1, a liquid comprising arginine or trometamol and citric acid, lactic acid or tartaric acid and a GLP-1 agonist (a poorly absorbable drug) is an ionic liquid.
Regarding instant claim 3, Towfly discloses the GLP-1 peptide may have the following sequence GGGCGGGCGGGHAEGTFTSDVSSYLEGQAAKEFIAWLCKGRGC (i.e., molecular weight of 4183 Da) [p. 9, SEQ ID 4].
One or ordinary skill in the art would have expected the peptide disclosed by Towfly to be water soluble because it is acidic. The sequence contains five acidic residues and two basic residues.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In present case the molecular weight of drug in the prior art falls within the instantly claimed range and a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the composition taught by Towfly to comprise a water-soluble drug with a molecular weight within the instantly claimed range.
2) Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Towfly Bioscience Co Ltd (CN 102363633 A, publication date 02/29/2012; citing English machine translation; hereinafter “Towfly”), in further view of Douglas et al. (US 2002/0037908 A1, publication date 04/12/2018).
Towfly, which is taught above, differs from the instant claims insofar as it does not disclose the specific water-soluble macromolecules of instant claim 5.
Douglas relates to an injectable formulation comprising an anion, a cation to deliver a protein assembly [abstract]. The composition may comprise a buffering agent such as citric acid and an additional agent such as polyvinyl pyrrolidone and hydroxypropyl methylcellulose [0038].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the polyvinyl pyrrolidone and hydroxypropyl methylcellulose of Douglas with the composition disclosed by Towfly. One would have been motivated to make this combination because Douglas discloses that buffering agents may comprise additional agents. One would have had an expectation of success because both Douglas and Towfly disclose an injectable solution comprising a polypeptide and citric acid as the buffering agent (i.e., pH adjusting agent). Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the composition taught by Towfly to further comprise a water-soluble macromolecule selected from polyvinyl pyrrolidone and hydroxypropyl methylcellulose.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1) Claim 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. US 12016924 B2 in view of “Hamamoto 1” (US 2019/0388544 A1, publication date 12/26/2019).
The claims of ‘924 discloses a “non-aqueous patch preparation comprising a drug solution in which a drug is dissolved in an organic solvent, wherein the organic solvent further comprises an ionic liquid” [claim 1].
The claims of ‘294 do not disclose the specific compounds of the ionic liquid.
Hamamoto 1, which is the priority document for ‘294, discloses “[t]he term “ionic liquid” in the present invention denotes a Brønsted salt prepared from a compound having carboxyl group(s) (an organic carboxylic acid) and an amine compound” [0039]. According to Hamamoto 1 suitable organic carboxylic acids are those having 3 to 7 carbons [0040], and suitable amine compounds include diethanolamine [0044]. Additionally, suitable drugs include GLP-1 agonists [0036].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have used an organic carboxylic acids are those having 3 to 7 carbons and diethanolamine for the ionic liquid and a GLP-1 agonists as the drug for the composition disclosed by the claims of ‘294 because they are disclosed as suitable options by Hamamoto 1. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated a composition comprising a poorly soluble drug and an ionic liquid comprising diethanolamine and an organic acid having 3 to 7 carbon atoms.
2) Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 10543275 B2 in view of “Hamamoto 2” (US 10543275 B2, date of patent 01/28/2020).
The claims of ‘275 disclose a “non-aqueous patch preparation comprising a drug solution in which a drug is dissolved in an ionic liquid” [claim 3], “wherein the ionic liquid comprises one or more alkanolamine organic carboxylates” [claim 4].
The claims of ‘275 do not disclose specific drugs and ionic liquids.
Hamamoto 2 discloses that suitable alkanolamines include diethanolamine [col. 6, line 14], suitable carboxylates include organic acids with 3 to 7 carbons [col. 3, lines 7-10] and suitable drugs include GlP-1 agonists [col. 5, line 26].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have used an organic carboxylic acids are those having 3 to 7 carbons and diethanolamine for the ionic liquid and a GLP-1 agonists as the drug because they are disclosed as suitable options by Hamamoto 2. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated a composition comprising a poorly soluble drug and an ionic liquid comprising diethanolamine and an organic acid having 3 to 7 carbon atoms.
Conclusion
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612