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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-17, 19, 23, and 24, and (a) octreotide and/or salt thereof somatostatin receptor agonist in the reply filed on 7/9/2026 is acknowledged.
Claims 18, 20-22, and 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected composition, method of use, method of cosmetic treatment, method of reducing oxidation, and process for preparing a pre-formulation composition, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/9/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/30/2023 has been considered by the examiner.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-17, 19, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Tiberg et al (WO 2012/160213 A1 (equivalent to US 2014/0162944 A1; for convenience purpose US 2014/0162944 is referenced in this rejection) in view of Nistor et al (US 2011/0230569 A1), Walker (US 2007/0185330 A1), Shamshina et al (Expert Opinion on Drug Delivery, 2013, 10:10, 1367-1381), and Patel et al (Appl Biochem Biotechnol, 2014, 172, 3701-3720).
Regarding claims 1-9, Tiberg et al teach a pre-formulation comprising: a) 20-80 wt. % of at least one diacyl glycerol and/or a tocopherol; b) 20-80 wt. % of at least one phosphatidyl choline (PC); c) 5-20 wt. % of at least one biocompatible, organic mono-alcoholic solvent; d) up to 20 wt. % polar solvent e) at least one peptide active agent; f) optionally at least one antioxidant,
wherein the wherein component a) comprises glycerol dioleate (GDO),
wherein component c) comprises ethanol, propanol, isopropanol or mixtures thereof,
wherein component d) comprises water or propylene glycol or mixtures thereof, wherein the peptide active agent comprises at least one somatostatin analogue selected from somatostatin 14, somatostatin 28, octreotide, lanreotide, pasireotide and vapreotide,
wherein the antioxidant is ascorbic acid, EDTA or citric acid,
wherein component d) is present at a level of 1.2 to 20% by weight. [see claims 1-12; 0020-0035, 0096-0097].
Further regarding claims 16 and 17, Tiberg et al further teach that the active agent is a peptide acetate and/or chloride [0103], such as octreotide chloride etc [see example 8], and peptide active agent is generally formulated as 0.02 to 12% by weight of the total formulation [0123].
Tiberg et al further teach that the antioxidant component is generally included in the range 0.0001 to 0.5% by weight of the total pre-formulation. Around 0.0005 to 0.015% of antioxidant (particularly EDTA) is particularly preferred, especially in combination with the other preferred components and ranges indicated herein above and below. Stability data using a number of different antioxidants demonstrate that EDTA antioxidants are surprisingly more efficient than other antioxidants in suppressing the oxidative degradation of bioactive agents. EDTA as antioxidant can also show a synergistic effect in combination with the antioxidants of the present invention, in maintaining the chemical and physical stability of the peptide active agent and complete pre-formulation. EDTA has a stabilizing effect on the active agent. [0157-0158].
Tiberg et al further teach the composition formed by exposure of pre-formulation components with aqueous fluids having liquid crystalline phase structures [see 0171 and examples 8 and 9], which reads on claim 19. As to instant claims 23 and 24, Tiberg teaches pre-filled devices and kits (see abstract, in particular).
The difference between Tiberg et al and instant claims is that Tiberg et al fails to teach alkyl ammonium EDTA salt as recited in claim 1.
Regarding claims 10-15, the above difference can be cured by the following references:
Nistor et al teach a formulation comprising: i) a lipid matrix; ii) at least one thiolated antioxidant; iii) optionally at least one bioactive agent; and iv) optionally at least one chelating agent, wherein said lipid matrix comprises: a) at least one diacyl glycerol and/or tocopherol; b) at least one phospholipid; c) at least one oxygenated organic solvent; and d) optionally at least one fragmentation agent, wherein the chelating agent is EDTA or its corresponding sodium, disodium, calcium etc. [see claims 1, 2, 6, 8 and 14; 0076].
Nistor et al teach the combination of a thiolated antioxidant compound and a chelating agent provides a highly effective combination in stabilizing the lipid based compositions of the invention. In all aspects of the invention, the antioxidant component may thus be supplemented with a chelator. Suitable chelating agents include any poly-dentate (including bi-dentate) ligand, including poly-acids, poly-amides, poly-amines and poly-ethers. Many metal-chelating ligands are known to those skilled in the art, and will be suitable for use in the present invention. Preferred chelating agents include diethylenetriaminepentaacetic acid (DTPA), ethylenediamine tetraacetic acid (EDTA) and the corresponding sodium, disodium and calcium disodium salts of EDTA. Without being bound by theory, it is thought that the metal chelating nature of the chelating agent serves to compliment the chain-breaking donating antioxidant property of the thiolated antioxidant, thus serving together to reduce the formation of oxygenated radical species, and quench those that do form. [see 0076-0079].
Walker teaches ionic liquids comprising an anion and a cation wherein the cation is a primary, secondary or tertiary ammonium ion containing a protonated nitrogen atom, wherein the preferred cation is ethanolammonium etc., and anion is EDTA etc. [0011, 0057 and 0060]. Walker also teaches applicants’ alkyl ammonium EDTA salt, viz., ethanolammonium ethylenediaminetetraacetate etc [see 0130, 0211, 0294, 0376, 0458], and advantages of ionic liquids in biological chemical reactions and drug delivery etc [0649-0655].
Shamshina et al teach advantages of ionic liquids in drug delivery [see abstract and section 6].
Patel et al teach applications of ionic liquids in protein stability and storage [see abstract and Table 1].
Based on the above established facts, all the claimed elements were known in the prior art, such as (i) applicants pre-formulation and its components, (ii) antioxidant and its role in the formulations, specifically stabilizing the formulations (iii) applicants’ alkyl ammonium EDTA salts, such as salt of ETA and EDTA, (iv) ionic liquids and their advantages in protein stability and drug delivery, and one skilled person in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Even though the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 2007), but such modifications are also axiomatic or obvious, because of their importance in the combinations with easily available technology to make them as evidenced from the above cited prior art, for two separate following reasons:
First, and specifically further regarding claims 12-15, one is motivated to develop alternative pre-formulation for the recited components, based on known individual compounds, in this case salt of ETA and EDTA, because advantages of ionic liquids and their use in stabilization of the formulations.
Second, as an alternative branch and specifically regarding claims 12-15, one is motivated to apply or expand, such to test the combination of art defined individual compounds, such as salt of ETA and EDTA, and its role in overall stability of the formulation, which can be used to obtain valuable information for existing field.
Hence, it is clear that under either of these two branches, “a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and that there would have been a reasonable expectation of success." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641, 1645.
Moreover, given the fact that there is always a need to target a disease or disorder differently to adopt with the constantly changing technology, without significantly altering its basic chemical process (first branch), or that there is always a need to reduce the time, cost or risk (second branch), and that there is only a limited number of ways that this can be done, it would be obvious to pursue a potential solution that has a reasonable expectation of success. See e.g. KSR International Co. v. Teleflex Inc., 1385, 1397; Pfizer, Inc. v. Apotex, Inc., 82 USPQ2d 1321; Alza Corp. v. Mylan Laboratories, Inc., 80 USPQ2d 1001; In re Kubin, 90 USPQ2d 1417; In re O’Farrell, 7 USPQ2d 1673, 1681; In re Eli Lilly & Co., 14 USPQ2d 1741; In re Ball Corp., 18 USPQ2d 1491.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed pre-formulation with a reasonable expectation of success. One would be motivated to replace EDTA with salt of ETA and EDTA in the teachings of Tiberg et al, EDTA and its salts are shown to be effective in stabilizing the lipid based compositions as evidenced from Nistor et al, and ionic liquids, such as salt of ETA and EDTA have greater range of advantages as evidenced form Walker, and Shamshina et al and Patel et al.
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 1-17, 19, 23, and 24 are1156 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11564968. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a pre-formulation comprising glycerol dioleate, phosphatidyl choline, EDTA, ethanol, and a specific somatostatin receptor agonist which may be octreotide and/or its salt, in overlapping amounts and kits or compositions thereof.
Claims 1-17, 19, 23, and 24 are1156 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11135264. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a pre-formulation comprising glycerol dioleate, phosphatidyl choline, EDTA, ethanol, and octreotide and/or its chloride salt, in overlapping amounts and kits or compositions thereof.
Claims 1-17, 19, 23, and 24 are1156 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 10688148. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a pre-formulation comprising glycerol dioleate, phosphatidyl choline, EDTA, ethanol, and octreotide and/or its chloride salt, in overlapping amounts and kits or compositions thereof.
Claims 1-17, 19, 23, and 24 are1156 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 12257282. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a pre-formulation comprising the same components specifically and expressly encompassing octreotide and/or its salt, in overlapping amounts and kits or compositions thereof.
Claims 1-17, 19, 23, and 24 are1156 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11241476. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a pre-formulation comprising glycerol dioleate, phosphatidyl choline, EDTA, ethanol, and an active agent which may be octreotide and/or its chloride salt, in overlapping amounts and kits or compositions thereof.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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