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 with traverse of species election in the reply filed on 4/2/2026 is acknowledged. The traversal is on the ground(s) that Saadeh et al. (US 2019/0134163 Al). This is found persuasive because Saadeh et al. did not teach all the limitations of amendment s to claim 1. Thus, all claims have unity of invention and examined in this office action.
Claim Status
Claims 1-3, 11, and 13-16 are pending.
Claims 4-10 and 12 are cancelled.
Claims 1-3, 11, and 13-16 have been examined.
Priority
This application is a 371 of PCT/CN2022/083523 filed on 03/29/2022 and claims CHINA 202110345922.6 filed on 03/31/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/18/2023 and 11/13/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 1, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Foger (US 2017/0304195 A1) in view of Saadeh et al. (US 2019/0134163 A1, cited in IDS), Taylor (AU 2014265076 A1), Luo et al. (CN 101843595 A), Taghizadeh et al. (Int J Biol Macromol. 2019 Jun 15:131:581-588), and del Valle et al. (Gels 2017, 3, 27).
A method of treating arthritis in a subject in need thereof comprising orally administering a formulation containing”:
adrenocorticotropic hormone (ACTH) or its derivatives selected from ACTH (1-39), ACTH (1-24) and ACTH (1-17);
a surfactant of sodium dodecyl sulphate;
a chitin or its derivative of chitosan;
a metal ion chelating agent of sodium citrate; and
the weight ratio of ACTH : sodium dodecyl sulphate : chitin : sodium citrate is
1.5-2.5: 19-21: 6-7: 60-70, or 0.20-0.30: 19-21: 6-7: 60-70, or 0.25-2.0: 19-21: 6-7: 60-70.
With respect to a method of oral administration of adrenocorticotropic hormone to treat arthritis in the preamble and the limitation (i) of adrenocorticotropic hormone (ACTH), Foger teaches a pharmaceutical formulations for the oral delivery of peptide or protein drugs (Abstract). Foger teaches the protein/peptide drug is adrenocorticotropic hormone (ACTH) or other hormone peptides [0033, claim 33]. Foger teaches the pharmaceutical composition is a solid composition or a liquid substantially water-free composition with less than 5% water [0067]. Foger teaches dosage forms of a protein drug (e.g., ACTH) for oral administration including tablets, capsules, emulsions, suspensions [0079]. Foger teaches the tablets containing excipients of sodium citrate [0080, 0272-Table 1] serving as a metal ion chelating agent [0136, 0292]. Foger teaches the oral dosage formulation further comprising sodium dodecyl sulfate and/or chitosan as an absorption enhancer for a solid dosage [0521]. Foger further teaches chitosan is also ale to chelate metal ions (claim 12) as well as serves as an absorption enhancer [0521]. Saadeh et al. is cited to show administration of adrenocorticotropic hormone (ACTH) to treat Rheumatoid arthritis including gout known in the art [0024]. Saadeh et al. show the active ingredient is ACTH (1-39), SEQ ID NO: 1, SYSMEHFRWGKPVGKKRRPVKVYPNGAEDELAEAFPLEF, [0039] or its
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functionally equivalent peptides of SEQ ID NOs: 2-4 as shown follows [0040]. Saadeh et al. teaches specific dose levels and frequency of administration depending on a variety of factors [0055], reading on the dose of administered adrenocorticotropic hormone (ACTH) as result effective variable subject to routine optimization such as 40 USP to 120 USP (claim 4). 1 USP unit equals to 0.01 mg as defined [0032]. Similarly, Taylor teaches the use of adrenocorticotropic hormone (ACTH) to treat a disease comprising rheumatoid arthritis [0117, 0120]. Similarly, Taylor teaches an agent (e.g., ACTH) can be formulated into preparations in solid, semi-solid, liquid or gaseous forms, such as tablets, capsules, powders, gels, microspheres for oral administration [0086]. Thus, treatment dosages will need to be titrated to optimize safety and efficacy. In general, each administration of the dosage regime will range from about 0.0001 to 100 mg/kg, and more usually 0.01 to 5 mg/kg of the host body weight [0122], further demonstrating the dosage of administered adrenocorticotropic hormone (ACTH) as result effective variable subject to routine optimization.
With respect to the limitation (ii), a surfactant of sodium dodecyl sulphate, Foger teaches the administration of an absorption enhancer improves or facilitates the mucosa! absorption of the peptide or protein drug in the gastrointestinal tract and is advantageous particularly if the peptide or protein drug is a large molecule, e.g., a peptide or protein drug having a molecular weight of about 1 kDa or more [0057]. Foger et al. show the use of sodium dodecyl sulfate as an absorption enhancer [0301, Table 7; 0521] and the effective amount of sodium dodecyl sulfate as an absorption enhancer is a result effective variable to be determined by routine experimentation (See [272, Table 1, 10 mg/ml] vs [0301, Table 7, 20 mg/ml]). Luo et al. is further cited to show the use of sodium lauryl sulphate (SDS) to improve the transcellular transport that membrane fluidity helps medicine with the protein regional interaction of epithelium in oral dosage formulation of a protein drug known in the art (p19, last para; claim 1).
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With respect to (iii) chitosan and (iv) sodium citrate, Foger teaches the tablets containing excipients of sodium citrate [0080, 0272-Table 1] serving as a metal ion chelating agent [0136, 0292]. Foger further teaches chitosan is also ale to chelate metal ions (claim 12) as well as serves as an absorption enhancer [0521]. Taghizadeh et al. teach citrate salts like sodium citrate with chelating behavior, which makes it possible to bind many ions, exhibits good potentials for use as a suitable cross-linking agent in preparation of chitosan nanoparticles under the ionic gelation process shown as follows (p582, Fig 1). Taghizadeh et al. teach chitosan-citrate complex has been already studied to make a delay in releasing drugs from matrix (reading on a sustained drug release carrier), microcapsule, and produced a pH dependent release of propranolol from coated tablets (p582, col 1, para 1) consistent with Foger’s drug filler [0080]. Taghizadeh et al. teach a weight ratio of sodium citrate to chitosan carrier is a result effective variable, which can be routinely optimized to synthesize chitosan carrier/beads with desired swelling and erosion properties (p583, col 2, para 2 and formulas 3-4) as well as load/release profile of a drug (p583, col 2, Sec 2.6). Similarly, del Valle et al. teach chitosan hydrogel for peptide/protein delivery (Title, Abstract). del Valle et al. teach hydrogels can be easily processed in different forms for coating and capsules for drug delivery (p15, 3rd last para). del Valle et al. teach chitosan can be used to create pH-, temperature- and ionic-strength-sensitive hydrogels as a drug carrier and chitosan can combine with other compounds to form hydrogels (p15, last para to p16, para 1). Taylor teaches an agent (e.g., ACTH) can be formulated into preparations in solid, semi-solid, liquid or gaseous forms, such as tablets, capsules, powders, gels, microspheres for oral administration [0086].
With respect to the weight ratio of ACTH : sodium dodecyl sulphate : chitin : sodium citrate, (a) Saadeh et al. teaches specific dose levels and frequency of administration depending on a variety of factors [0055], reading on the dose of administered adrenocorticotropic hormone (ACTH) as result effective variable subject to routine optimization such as 40 USP to 120 USP (claim 4). 1 USP unit equals to 0.01 mg as defined [0032], reading on 0.4 mg to 1.2 mg. Similarly, Taylor teaches treatment dosages will need to be titrated to optimize safety and efficacy. In general, each administration of the dosage regime will range from about 0.0001 to 100 mg/kg, and more usually 0.01 to 5 mg/kg of the host body weight, further demonstrating the dose of administered adrenocorticotropic hormone (ACTH) as result effective variable subject to routine optimization. Taghizadeh et al. teach a weight ratio of sodium citrate to chitosan carrier is a result effective variable, which can be routinely optimized to synthesize chitosan carrier/beads with desired swelling and erosion properties (p583, col 2, para 2 and formulas 3-4) as well as load/release profile of a drug (p583, col 2, Sec 2.6) and (b) Foger et al. show the use of sodium dodecyl sulfate as an absorption enhancer [0301, Table 7; 0521] and the effective amount of sodium dodecyl sulfate as an absorption enhancer is a result effective variable to be determined by routine experimentation (See [272, Table 1, 10 mg/ml] vs [0301, Table 7, 20 mg/ml]). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II)(A).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Foger in view of Saadeh et al. and Taylor with (ii) Luo et al. because (a) Foger teaches a pharmaceutical formulations for the oral delivery of a protein drug (e.g., ACTH) [0033, claim 33] and the effective amount of sodium dodecyl sulfate in formulation of ACTH as an absorption enhancer is a result effective variable to be determined by routine experimentation (See [272, Table 1, 10 mg/ml] vs [0301, Table 7, 20 mg/ml]), (b) Saadeh et al. is cited to show administration of adrenocorticotropic hormone (ACTH) to treat Rheumatoid arthritis including gout known in the art [0024], (c) Taylor teaches the use of adrenocorticotropic hormone (ACTH) to treat a disease comprising rheumatoid arthritis [0117, 0120] and the dosage regime of ACTH is a result effective variable subject to routine optimization optimized from about 0.0001 to 100 mg/kg, and more usually 0.01 to 5 mg/kg of the host body weight [0122], and (d) Luo et al. is further cited to show the use of sodium lauryl sulphate (SDS) to improve the transcellular transport that membrane fluidity helps medicine with the protein regional interaction of epithelium in oral dosage formulation of a protein drug known in the art (p19, last para; claim 1). The combination would have reasonable expectation of success because all four references teach formulation of an oral protein drug.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Foger in view of Saadeh et al., Taylor and Luo et al. with (ii) Taghizadeh et al.in view of del Valle et al. because (a) Foger in view of Saadeh et al., Taylor and Luo et al. teach an oral formulation of ACTH comprising chitosan ale to chelate metal ions (Foger’s claim 12) and serve as an absorption enhancer [Foger’s 0521] and sodium citrate [0080, 0272-Table 1], (b) Taghizadeh et al. teach sodium citrate with chelating behavior for use as a suitable cross-linking agent in preparation of chitosan nanoparticles under the ionic gelation process (p582, Fig 1). Taghizadeh et al. teach chitosan-citrate complex has been already studied to make a delay in releasing drugs from matrix, microcapsule, and produced a pH dependent release of propranolol from coated tablets (p582, col 1, para 1), and (c) del Valle et al. teach chitosan can be used to create pH-, temperature- and ionic-strength-sensitive hydrogels as a drug carrier and chitosan can combine with other compounds to form hydrogels (p15, last para to p16, para 1). The combination would have reasonable expectation of success because All references of Foger, Taghizadeh et al., and del Valle et al. teach the use of chitosan in formulation of a drug.
With respect to claim 11, Saadeh et al. teaches specific dose levels and frequency of administration depending on a variety of factors [0055], reading on the dose of administered adrenocorticotropic hormone (ACTH) as result effective variable subject to routine optimization such as 40 USP to 120 USP (claim 4). 1 USP unit equals to 0.01 mg as defined [0032], reading on 0.4 mg to 1.2 mg. Similarly, Taylor teaches treatment dosages will need to be titrated to optimize safety and efficacy. In general, each administration of the dosage regime will range from about 0.0001 to 100 mg/kg, and more usually 0.01 to 5 mg/kg of the host body weight [0122].
With respect to claim 13, the effective amount of ACTH, sodium dodecyl sulphate, chitosan, and sodium citrate are all result effective variables that can be optimized via routine experimentation. Saadeh et al. teaches specific dose levels and frequency of administration depending on a variety of factors [0055], reading on the dose of administered adrenocorticotropic hormone (ACTH) as result effective variable subject to routine optimization such as 40 USP to 120 USP (claim 4). 1 USP unit equals to 0.01 mg as defined [0032], reading on 0.4 mg to 1.2 mg. Other weights of sodium dodecyl sulphate, chitosan, and sodium citrate can be optimized related to the weight of ACTH.
2. Claims 1-2, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. as applied to claims 1, 11, 13 and further in view of Rock et al. (Nat Rev Rheumatol. 2013 January ; 9(1): 13–23).
Claim 2 is drawn to the arthritis includes gout caused by a high uric acid level.
Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. teach a method comprising oral administration of ACTH formulation to treat Rheumatoid arthritis including gout as applied to claims 1, 11, and 13 above.
Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. did not specify gout caused by a high uric acid level.
Rock et al. teach “Uric acid as a danger signal in gout and its comorbidities” (Title). Rock et al. teach gout is triggered when crystals of monosodium urate (MSU) - a crystallized form of uric acid - nucleate in joints, kidneys and other tissues, where they incite inflammation (p1, Introduction). Rock et al. teach the pathogenesis of gout with elevating serum levels of uric acid (p9, Uric acid and comorbidities of gout, para 1), reading on claim 2.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. with (ii) Rock et al. because (a) Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. teach a method comprising oral administration of ACTH formulation to treat Rheumatoid arthritis including gout and (b) Rock et al. teach the pathogenesis of gout with elevating serum levels of uric acid (p9, Uric acid and comorbidities of gout, para 1). The combination would have reasonable expectation of success because both Saadeh et al. and Rock et al. teach a method to treat gout.
3. Claims 1, 3, 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., del Valle et al. as applied to claims 1, 11, 13 and further in view of Jelena et al. (Eur J Drug Metab Pharmacokinet. 2005 Jan-Jun;30(1-2):99-104).
Claim 3 is drawn to the excipients further comprise an acrylic polymer, the acrylic polymer is Carbomer.
Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. teach a method of orally administering an ACTH formulation comprising various excipients and carrier (sodium citrate crosslinked chitosan as a sustained released drug carrier) to treat Rheumatoid arthritis.
Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. do not specify the formulation further comprising carbomer polymer.
Jelena et al. teach “Biopharmaceutical characterization of sustained release matrix tablets based on novel carbomer polymers: formulation and in vivo investigation” (Title). Jelena et al. teach novel carbomer polymers, Carbopol 971P and Carbopol 71G, as sustained release agents in matrix tablets containing high dosage drug substance. Although chemically identical, the two polymers exhibited substantially different drug release properties in vitro. Jelena et al. teach in vivo drug release profiles as result effective variable that can be optimized by urinary excretion data (p99, summary) shown in figure 3 (p103). Because the beneficial use of acrylic polymers, Carbopol 971P and/or Carbopol 71G, for sustained release of loaded drug from an oral dosage formulation, one of ordinary skill in the art would have found it obvious to beneficial add carbomer polymers in formulation of ACTH for further improving sustained release of ACTH from an oral dosage of ACTH. The weight ratio of carbomer polymers in formulation of a drug (e.g., ACTH), like other weight ratio of excipients in rejection of claim 1 described above, is also a result effective variable that can be optimized by routine experimentation with urinary excretion data as taught by Jelena et al. (p99, summary; p103, Fig. 3), reading on claim 3. See MPEP 2144.05 (II)(A).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. with (ii) Jelena’s carbomer polymers because (a) Foger in view of Saadeh et al., Taylor, Luo et al., Taghizadeh et al., and del Valle et al. teach a method comprising oral administration of ACTH in a sustained released formulation in an oral dosage form to treat Rheumatoid arthritis including gout and (b) Jelena et al. teach the use of carbomer polymers, Carbopol 971P and Carbopol 71G, as sustained release agents in matrix tablets containing high dosage drug substance. The combination would have reasonable expectation of success because all Taghizadeh et al., del Valle et al., and Jelena et al. teach a drug in sustained release formulation.
Claims 14-16 are directed the weight of ACTH and excipients used in formulation of ACTH. Saadeh et al. teaches specific dose levels and frequency of administration depending on a variety of factors [0055], reading on the dose of administered adrenocorticotropic hormone (ACTH) as result effective variable subject to routine optimization such as 40 USP to 120 USP (claim 4). 1 USP unit equals to 0.01 mg as defined [0032], reading on 0.4 mg to 1.2 mg. Similarly, Taylor teaches treatment dosages will need to be titrated to optimize safety and efficacy. In general, each administration of the dosage regime will range from about 0.0001 to 100 mg/kg, and more usually 0.01 to 5 mg/kg of the host body weight, further demonstrating the dose of administered adrenocorticotropic hormone (ACTH) as result effective variable subject to routine optimization. The examiner found claims 13-16 are directed optimization results based
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on the amount of ACTH to the excipients. The prior art references teach a range of ACTH overlapping with the claimed ACTH summarized by the examiner as shown follows. Furthermore, individual cited references teach the amount of claimed excipients are also result effective variable subject to optimization described in the rejection above. See MPEP 2144.05(II)(A). "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
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 1-3, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-4 of U.S. Patent No. 12,097,245 (the ‘245 patent) in view of Foger (US 2017/0304195 A1), Saadeh et al. (US 2019/0134163 A1), Taylor (AU 2014265076 A1), Rock et al. (Nat Rev Rheumatol. 2013 January ; 9(1): 13–23), and Jelena et al. (Eur J Drug Metab Pharmacokinet. 2005 Jan-Jun;30(1-2):99-104).
Claim 1 of the ‘245 patent disclosed a peptide formulation for promoting small-intestinal absorption consists of sodium lauryl sulfate (SDS), carbomer, chitosan, and sodium citrate.
Claim 3 of the ‘245 patent disclosed weight ratio of sodium lauryl sulfate (SDS), carbomer, chitosan, and sodium citrate as 15-25:5-8:5-8:50-80.
Claim 4 of ‘245 patent disclosed weight ratio of the peptide drug to the sum of excipients at 1:5-860.
Claims 1 and 3-4 of the ‘245 patent did not disclosed a formulated peptide drug as ACTH.
Foger in view of Saadeh et al., Taylor, Rock et al. and Jelena et al. teach a method of orally administering an ACTH formulation comprising substantially the same excipients to treat Rheumatoid arthritis including gout described above, not repeated here.
Because Foger in view of Saadeh et al., Taylor, Rock et al. and Jelena et al. teach administration of a peptide formulation comprising ACTH peptide and substantially the same excipients taught by claims 1 and 3-4 of the ‘245 patent to treat Rheumatoid arthritis including gout, one of ordinary skill in the art would have found it obvious to beneficially substitute a GLP-1 receptor agonist peptide by an ACTH peptide in a formulation comprising sodium lauryl sulfate, carbomer, chitosan, and sodium citrate for promoting small-intestinal absorption. Claim 4 of ‘245 patent disclosed weight ratio of a peptide drug to the sum of excipients at 1:5-860; thus, it would be obvious to optimize the weight ratio of ACTH to the sum of excipients at 1: 5-860.
Thus, claims 1 and 3-4 of the ‘245 patent in view of Foger, Saadeh et al., Taylor, Rock et al. and Jelena et al. are obvious to the instant claims 1-3, 11, and 13-16.
Claims 1-3, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-4 of U.S. Patent No. 12,036,197 (the ‘197 patent) in view of Foger (US 2017/0304195 A1), Saadeh et al. (US 2019/0134163 A1), Taylor (AU 2014265076 A1), Rock et al. (Nat Rev Rheumatol. 2013 January ; 9(1): 13–23), and Jelena et al. (Eur J Drug Metab Pharmacokinet. 2005 Jan-Jun;30(1-2):99-104).
Claim 1 of the ‘197 patent disclosed an excipient composition for oral administration comprising a surfactant, an acrylic polymer, chitin or its derivatives, and a metal ion chelating agent in a weight ratio of 15-25:5-8:5-8:50-80.
Claim 7 of the ‘197 patent disclosed surfactant is sodium lauryl sulfate (SDS), the acrylic polymer is carbomer, the chitin or its derivatives are chitosan, and the metal ion chelating agent is sodium citrate.
Claim 8 of the ‘197 patent disclosed the weight ratio of surfactant, the acrylic polymer, the chitin or its derivatives, and the metal ion chelating agent in a weight ratio of 19-21:6-7:6-7:60-70.
Claims 9-10 of the ‘197 patent disclosed the active ingredient is ACTH.
Claim 12 of the ‘197 patent disclosed the composition is prepared into an enteric capsule.
Claims 1, 7-10 and 12 of the ‘197 patent did not disclose administration of ACTH to treat arthritis.
Foger in view of Saadeh et al., Taylor, Rock et al. and Jelena et al. teach a method of orally administering an ACTH formulation comprising substantially the same excipients to treat Rheumatoid arthritis including gout described above, not repeated here.
Because Foger in view of Saadeh et al., Taylor, Rock et al. and Jelena et al. teach beneficial use of an oral dosage formulation (e.g., capsule) comprising ACTH and substantially the same excipients as taught by claims 1, 7-10 and 12 of the ‘197 patent to treat Rheumatoid arthritis including gout, one of ordinary skill in the art would have found it obvious to combine claims 1, 7-10 and 12 of the ‘197 patent and Foger in view of Saadeh et al., Taylor, Rock et al. and Jelena et al. to treat Rheumatoid arthritis including gout.
Thus, claims 1, 7-10 and 12 of the ‘197 patent in view of Foger, Saadeh et al., Taylor, Rock et al. and Jelena et al. are obvious to the instant claims 1-3, 11, and 13-16.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
06-June-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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