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 .
DETAILED ACTION
Applicant’s preliminary amendment submitted on 30 January 2024, in which claims 2, 4, 6, 10, 12, 23, 27, 29, 36 have been amended, and claims 3, 5, 11, 24, 28, 30, 37 have been cancelled, is acknowledged.
Claims 1-2, 4, 6-10, 12-23, 25-27, 29, 31-36, 38-43 are pending.
Claims 18-23, 25-27, 29, 31-36, 38-43 are withdrawn, as being drawn to a non-elected invention.
Claims 1-2, 4, 6-10, 12-17 are being examined herewith.
Priority
The instant application, filed on 19 October 2023, claims priority from U.S. Provisional Patent Application No. 63/380,090, filed on 19 October 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1 May 2024 and 22 July 2025 are acknowledged and considered.
Election/Restrictions
Applicant’s election without traverse of Group (I), claims 1-2, 4, 6-10, 12-17, drawn to a therapeutic formulation comprising: (a) a therapeutic agent selected from levothyroxine and a salt thereof; (b) at least one ionization stabilizing excipient; and (c) an aprotic polar solvent system, in the reply filed on 22 December 2025, is acknowledged. Claims 18-23, 25-27, 29, 31-36, 38-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Applicant’s election without traverse of sulfuric acid as the species of (b) one ionization stabilizing excipient; the election of DMSO as the (c) aprotic polar solvent system; the election of trehalose dihydrate as the sugar; the election of mannitol as the sugar alcohol; and the election of PLGA as the polymer present in the formulation, in the reply of 22 December 2025, is acknowledged. Claims 1-2, 4, 6-10, 12-17 read on the elected species.
Claims 1-2, 4, 6-10, 12-17 have been examined to the extent they read on the elected species and the following objections and rejections are made below.
Claim objection
Claims 18-23, 25-27, 29, 31-36, 38-43, while currently withdrawn, are objected to because of the following informality: The withdrawn claims are objected to for being presented in a non-compliant form. Specifically, the claims are withdrawn because of the election made by the Applicant on 22 December 2025. As such, claims 18-23, 25-27, 29, 31-36, 38-43 should be identified as "(Withdrawn)" until such time as examiner rejoins the claims for examination. Appropriate correction is required. See MPEP 714(C).
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 16, 17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 is drawn to the formulation of claim 12, wherein the polymer is PLGA. Yet, claim 12 does not recite a polymer. As such, there is insufficient antecedent basis for the recitation “the polymer” of claim 16, in claim 12.
Appropriate correction is required.
In the interest of compact prosecution, claim 16 is considered to be dependent on claim 10.
Claims 8, 9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 8, 9 depend on claim 1 and recite sulfuric acid; yet, claim 1 does not recite sulfuric acid. As such, there is insufficient antecedent basis for the term “sulfuric acid” of claims 8, 9, in claim 1.
In the interest of compact prosecution, the examiner considers that claims 8, 9 depend on claim 6.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 interpretation: The term “extended period of time” in claim 1 is interpreted as referring to an interval of time when therapeutic blood levels/concentrations are achieved with the therapeutic agent in an extended release formulation, relative to an immediate release formulation comprising the same therapeutic agent [0015].
Claims 1-2, 4, 6-10, 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan et al. (US 2020/0376083, published 3 December 2020, cited in IDS), in view of Makadia et al. (Polymers (Basel) 2011, 3 (3), 1377-1397, cited in IDS).
Donovan (US 2020/0376083) teaches (Abstract, [0025], [0080]) a stable formulation comprising:
(a) therapeutic agent;
(b) an ionization stabilizing excipient;
(c) an aprotic polar solvent system which is dimethyl sulfoxide (DMSO)-based solvent system, as in instant claim 7.
Donovan teaches [0085] that the therapeutic agent in the formulation of the invention is, for example, glucagon [0084] or is [0085], for example, small molecule levothyroxine or salts thereof, as in the instant claims. Thus, Donovan teaches glucagon and small molecule levothyroxine/salts thereof being used interchangeably in the formulations of the invention.
Donovan teaches [0102] that the formulations can contain therapeutic agent small molecule; the concentrations for small molecules are known to medical personnel and can be established and implemented using the disclosure provided herein, e.g., 0.01 mg/ml to 500 mg/ml, including all values and ranges there between, which is within the range in instant claims 8, 9.
Donovan teaches [0013] that the ionization stabilizing excipient is a mineral acid selected from hydrochloric acid, nitric acid, phosphoric acid, as in instant claim 4, and sulfuric acid, as in instant claims 4, 6, 8, 9. Donovan teaches [0013] that the ionization stabilizing excipient can be dissolved in the aprotic solvent in an amount to stabilize the ionization of the therapeutic agent. The ionization stabilizing excipient is at a concentration of 0.01 mM to less than 200 mM, which is within the range in instant claims 8, 9.
Donovan specifically teaches (Table 3) a formulation containing
(a) a therapeutic agent (glucagon), wherein the concentration of the therapeutic agent is as in instant claim 8;
(b) an ionization stabilizing excipient which is sulfuric acid, as in instant claims 4, 6; and
(c) an aprotic polar solvent which is dimethyl sulfoxide (DMSO), as in instant claim 7; further comprising trehalose dihydrate, as in instant claims 10, 12, 13; and mannitol, as in instant claim 14.
Donovan teaches [0014] that the formulations can further include a preservative, as in instant claim 10; the preservative is benzyl alcohol, as in instant claim 15.
Donovan teaches [0015] that the formulations can further include a disaccharide trehalose, as in instant claims 10, 12, 13.
Donovan teaches [0082] that the formulations of the invention can include one or more other excipients in addition to the (at least one) ionization stabilizing excipient, such as sugars, sugar alcohols, preservatives, as in instant claim 10.
Donovan teaches [0044] measures the stability of the formulation storage of the product at 25° C./60% relative humidity for one month, two months, and preferably three months. Donovan teaches a physically stable formulation has less than less than 15%, less than 10%, less than 5%, less than 4%, less than 3%, less than 2%, or less than 1% aggregates formed after an extended period of storage at the intended storage temperature of the product.
Donovan does not specifically exemplify a formulation of levothyroxine or sodium salt thereof, as in the instant claims.
Donovan does not teach PLGA in the formulation, as in instant claims 16, 17.
Makadia et al. (Polymers (Basel) 2011, 3 (3), 1377-1397) teaches poly lactic co-glycolic acid as biodegradable controlled drug delivery carrier. Makadia teaches (Abstract) that PLGA is biocompatible and biodegradable, has tunable mechanical properties, is FDA approved, and has been extensively studies for controlled delivery of small molecule drugs.
Regarding claims1-2, 4, 6-10, 12-15, it would have been obvious to a person of ordinary skill in the art to use the teachings of Donovan to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to prepare a formulation comprising levothyroxine or sodium salt thereof, sulfuric acid, DMSO, further comprising a sugar trehalose, mannitol sugar alcohol, benzyl alcohol preservative, because Donovan teaches these very ingredients in a stable formulation of a therapeutic agent small molecule such as levothyroxine or salt thereof. Thus, a person of ordinary skill in the art would have combined the ingredients taught by Donovan in a formulation, with the expectation that the resulting formulation is stable.
Further, the person of ordinary skill in the art would have been motivated to replace therapeutic ingredient glucagon with levothyroxine or its sodium salt, in a formulation Table 3 taught by Donovan, comprising sulfuric acid, and DMSO, further comprising trehalose dihydrate, and mannitol, because Donovan teaches glucagon and small molecule levothyroxine/salts thereof being used interchangeably in the formulations of the invention. Thus, a person of ordinary skill in the art would have replaced therapeutic ingredient glucagon with levothyroxine or its sodium salt, in a formulation Table 3 taught by Donovan, with the expectation that the resulting formulation is stable.
Further, regarding claims 8, 9, the person of ordinary skill in the art would have varied the concentration of levothyroxine or its sodium salt, and the concentration of sulfuric acid in the formulation, within the ranges taught by Donovan, because such optimization of therapeutic agent / sulfuric acid concentration/amount in order to optimize therapeutic effect and stability of the composition is routine, well within the skill of the artisan.
Even though Donovan does not specifically teach that the formulation, when administered to a patient, results in the presence of therapeutic levels of levothyroxine in the blood of said patient for an extended period of time relative to an immediate release formulation comprising levothyroxine, as in instant claims, the ability to maintain therapeutic blood levels of levothyroxine in patients upon administration, is an inherent property of the formulation. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
While Donovan does not explicitly teach “wherein said formulation is storage stable for at least six months at 2-8 °C”, as in instant claims, the claimed limitation appears to be a result or property of the formulation. As such, the claimed limitations appears to be met by the prior art. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on the applicant to prove that the function of the product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 16, 17, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Donovan and Makadia to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to add PLGA as acid-terminated PLGA to such formulation, because Makadia teaches that PLGA is biocompatible and biodegradable, and has been extensively studies for controlled delivery of small molecule drugs. Thus, the person of ordinary skill in the art would have added PLGA to the formulation, with the expectation that the resulting formulation retains therapeutic effect and improved drug delivery properties.
As such, claims 1-2, 4, 6-10, 12-17 are rejected as prima facie obvious.
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.
Claims 1-2, 4, 6-10, 12-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, 8-13, 15-19 of co-pending U.S. Patent Application No. 18/490,224 (cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because a composition of claims 1-3, 5, 6, 8-13, 15-19 of co-pending U.S. Patent Application No. 18/490,224 renders obvious a composition of instant claims.
Claims 1-3, 5, 6, 8-13, 15-19 of co-pending U.S. Patent Application No. 18/490,224 are drawn to a storage stable sustained release therapeutic formulation comprising: (a) at least one therapeutic agent; (b) at least one ionization stabilizing excipient; and (c) an aprotic polar solvent system;
claims 2, 3 recite that the therapeutic agent is levothyroxine free acid or levothyroxine sodium, as in the instant claims;
claim 5 recites that the aprotic polar solvent system comprises or is dimethyl sulfoxide (DMSO), as in instant claim 7;
claims 6, 8 recite that the mineral acid is sulfuric acid, as in instant claims 4, 6;
claims 11, 12 recite the concentrations of levothyroxine sodium and sulfuric acid in the formulation, which overlap with the concentrations in instant claims 8, 9;
claim 13 recites a sugar, a sugar alcohol, a preservative, and a polymer as additional excipients in the formulation, as in instant claim 10.
Claims 15, 16 recite that the sugar is trehalose or a salt or hydrate thereof, as in instant claims 12, 13;
claim 17 recites that the sugar alcohol is mannitol, as in instant claim 14;
claim 18 recites that the preservative is a benzyl alcohol, as in instant claim 15; and
claim 19 recites that the polymer is a poly(lactic-co- glycolic acid) (PLGA), wherein said PLGA is an ester-terminated PLGA or an acid-terminated PLGA, as in instant claims 16, 17.
Claims 1-3, 5, 6, 8-13, 15-19 of co-pending U.S. Patent Application No. 18/490,224 recite a formulation containing the same ingredients as in the instant claims, in similar concentrations.
As such, claims 1-2, 4, 6-10, 12-17 are rendered obvious by a composition taught by claims 1-3, 5, 6, 8-13, 15-19 of co-pending U.S. Patent Application No. 18/490,224.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4, 6-10, 12-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent 12,514,837 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because a composition of claims 1-6 of U.S. Patent 12,514,837 anticipates or renders obvious a composition of instant claims.
Claims 1-6 of U.S. Patent 12,514,837 are drawn to a storage stable therapeutic formulation, comprising: (a) a therapeutic agent, which is levothyroxine or a salt thereof, at a concentration of about 10 mg/mL; (b) an ionization stabilizing excipient, which is sulfuric acid, at a concentration of about 26 mM to about 32 mM; (c) an aprotic polar solvent, which is dimethyl sulfoxide (DMSO); (d) a sugar, which is trehalose or a salt or hydrate thereof, at a concentration of about 5.5% (w/v); and (e) a sugar alcohol, which is mannitol, at a concentration of less than 3.0% (w/v);
claims 2, 3 recite that the therapeutic agent is levothyroxine sodium, as in instant claims 2, 8, 9;
claim 5 recites trehalose dihydrate as the sugar in the composition, as in instant claims 12, 13;
claim 6 recites benzyl alcohol as preservative in the composition, as in instant claim 15.
Claims 1-6 of U.S. Patent 12,514,837 recite a formulation containing the same ingredients as in the instant claims, in similar concentrations.
As such, claims 1-2, 4, 6-10, 12-17 are anticipated or rendered obvious by a composition taught by claims 1-6 of U.S. Patent 12,514,837.
Claims 1-2, 4, 6-10, 12-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 41, 44, 46-49, 51, 53-54 of co-pending U.S. Patent Application No. 18/627,095 (cited in PTO-892), in view of Donovan et al. (US 2020/0376083, published 3 December 2020, cited in IDS), in further view of Makadia et al. (Polymers (Basel) 2011, 3 (3), 1377-1397, cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because a composition of claims 41, 44, 46-49, 51, 53-54 of co-pending U.S. Patent Application No. 18/627,095 renders obvious a composition of instant claims.
Claims 41, 44, 46-49, 51, 53-54 of co-pending U.S. Patent Application No. 18/627,095 are drawn to a stable aprotic polar solvent formulation comprising:(a) levothyroxine, or salt thereof; (b) an ionization stabilizing excipient; (c) an aprotic polar solvent;
claim 49 recites that the aprotic polar solvent is dimethyl sulfoxide (DMSO), as in instant claim 7;
claims 47, 48 recite that the ionization stabilizing excipient is a mineral acid, and the mineral acid is, for example, sulfuric acid, as in instant claims 4, 6;
claims 44, 46 recite the concentrations of levothyroxine sodium and sulfuric acid in the formulation, which overlap with the concentrations in instant claims 8, 9;
claim 51 recites a preservative as additional excipient in the formulation, as in instant claim 10;
claims 53, 54 recite a disaccharide in the formulation, which is trehalose, as in instant claims 12, 13.
Claims 41, 44, 46-49, 51, 53-54 of co-pending U.S. Patent Application No. 18/627,095 do not recite mannitol sugar alcohol, as in instant claim 14, benzyl alcohol, as in instant claim 15, or a polymer which is poly(lactic-co- glycolic acid) (PLGA), as in instant claims 16, 17, as additional ingredients in the formulation.
Donovan (US 2020/0376083) teaches sugar alcohol which is mannitol, and a preservative which is benzyl alcohol, as in instant claims 14, 15, as additional ingredients in a formulation comprising levothyroxine, or salt thereof; an ionization stabilizing excipient; and an aprotic polar solvent.
Makadia is as above.
Claims 41, 44, 46-49, 51, 53-54 of co-pending U.S. Patent Application No. 18/627,095 recite a formulation containing the same ingredients as in instant claims 1-2, 4, 6-10, 12-13, in similar concentrations.
Regarding claims 14-15, it would have been obvious to a person of ordinary skill in the art to combine the teachings of claims 41, 44, 46-49, 51, 53-54 of co-pending U.S. Patent Application No. 18/627,095 and Donovan to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to add mannitol sugar alcohol and benzyl alcohol preservative to a formulation of claims 41, 44, 46-49, 51, 53-54 of co-pending U.S. Patent Application No. 18/627,095, because Donovan teaches mannitol and benzyl alcohol as additional ingredients in a formulation comprising levothyroxine, or salt thereof; an ionization stabilizing excipient; and an aprotic polar solvent.
Regarding claims 16, 17, it would have been obvious to a person of ordinary skill in the art to combine the teachings of claims 41, 44, 46-49, 51, 53-54 of co-pending U.S. Patent Application No. 18/627,095 and Makadia to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to add PLGA as acid-terminated PLGA to such formulation, because Makadia teaches that PLGA is biocompatible and biodegradable, and has been extensively studies for controlled delivery of small molecule drugs. Thus, the person of ordinary skill in the art would have added PLGA to the formulation, with the expectation that the resulting formulation retains therapeutic effect and improved drug delivery properties.
As such, claims 1-2, 4, 6-10, 12-17 are rendered obvious by a composition taught by claims of co-pending U.S. Patent Application No. 18/627,095.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2, 4, 6-10, 12-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629