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 .
This is the second Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Reply filed 28 April 2026, Applicant amended claims 2, 4-7, 11-15, 19, 24-27 and 31; cancelled claims 3, 10 and 23; and added one new claim, i.e., claim 32. Claim 1 was cancelled previously by Applicant. Claims 2, 4-9, 11-22, and 24-32 are pending.
Status of the Rejections and Objections
The objection to the title of the invention is withdrawn in view of Applicant’s amendment thereto.
The rejection of claims 2-31 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s clarifying amendments to claims 2, 24, and 31. The examiner appreciates Applicant’s effort to advance prosecution.
The rejection of (new) claim 32 under 35 U.S.C. 112(b) is new.
The rejection of claim 31 under 35 U.S.C. 112(d) is new and is necessitated by Applicant’s amendment to claim 2.
The rejection of claims 2-9 and 14-31 under 35 U.S.C. 103 as being unpatentable over Fellstrom (“Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial.” The Lancet 389.10084 (2017): 2117-2127) in view of Calliditas Therapeutics (“Pharmalink’s core patents for Nefecon® treatment for renal disease granted in United States, Europe, China and Hong Kong.” 2014 July 10. [Press Release]), Watts (US 8,491,932 B2), and Villa (US 9,192,581 B2) is withdrawn in view of Applicant’s narrowing amendments to claim 2.
The rejection of claims 10-13 under 35 U.S.C. 103 as being unpatentable over Fellstrom in view of Calliditas Therapeutics, Watts and Villa, as applied above to claims 2-9 and 14-31, and further in view of Gareb (“Development of novel zero-order release budesonide tablets for the treatment of ileo-colonic inflammatory bowel disease and comparison with formulations currently used in clinical practice.” Int’l Journal of Pharmaceutics 554 (2019): 366-375) is withdrawn in view of Applicant’s narrowing amendments to claim 2. The examiner notes that none of Applicant’s claims previously required that the disintegrant is present in the core of the tablet. See, e.g., claim 10 (now cancelled).
The rejection of claims 2, 4-9, 11-22, and 24-32 are rejected under 35 U.S.C. 103 as being unpatentable over Fellstrom (“Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial.” The Lancet 389.10084 (2017): 2117-2127) in view of Calliditas Therapeutics (“Pharmalink’s core patents for Nefecon® treatment for renal disease granted in United States, Europe, China and Hong Kong.” 2014 July 10. [Press Release]), Watts (US 8,491,932 B2), Villa (US 9,192,581 B2), and Gareb 2016 (“Development of a zero-order sustained-release tablet containing mesalazine and budesonide intended to treat the distal gastrointestinal tract in inflammatory bowel disease.” European Journal of Pharmaceutics and Biopharmaceutics 103 (2016): 32-42) is new and is necessitated by Applicant’s narrowing amendments to claim 2. The examiner notes that Gareb 2016 is newly cited.
All three provisional rejections on the ground of non-statutory double patenting have been modified in view of Applicant’s narrowing amendments to claim 2. Specifically, Gareb 2016 has been substituted for Gareb 2019 as the tertiary reference.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claim 32 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Claim 32, which depends on claim 2, recites the following limitation: “wherein at least 90% of the budesonide is released to the ileum region, thereby treating said IgA nephropathy.” A person having ordinary skill in the art — even after reviewing the specification of the present application — would not be able to discern with reasonable certainty the structural or compositional implications of the foregoing functional limitation, which concerns the release profile of the one or more budesonide tablets administered in claim 2. MPEP § 2173.05(g) (“the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite.”). How does the foregoing release clause further limit the structural/compositional profile of the one or more budesonide tablets of claim 2, which tablets merely require an enterically-coated core, wherein the core comprises budesonide, a gelling matrix material, and a disintegrant? It is important to recognize that “when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.” MPEP § 2173.05(g) (citing Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008) (emphasis added)). With this in mind, the examiner concludes that claim 32 is indefinite.
Claim Rejections - 35 U.S.C. 112(d)
The following is a quotation of 35 U.S.C. 112(d):
[A] claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 31 is rejected under 35 U.S.C. 112(d) as being of improper dependent form.
Limitation (a) of claim 31 recites: “no more than about 10% of the budesonide is released into an aqueous dissolution medium with a pH of about 1.2 within about 120 minutes.” The examiner notes that a pH of about 1.2 corresponds to stomach fluid, primarily in the fasted stated. However, claim 2 (as recently amended) now recites that “the one or more tablets prevent release of the budesonide until the ileum region of the small intestine is reached.” Thus, claim 2 implies that no budesonide release occurs in the stomach. Claim 31 conflicts with claim 2 in that it allows up to about 10% of the budesonide to be released in the gastrointestinal system prior to the ileum. Consequently, claim 31 fails to comply with 35 U.S.C. 112(d).
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 U.S.C. 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.
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(a) 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 2, 4-9, 11-22, and 24-32 are rejected under 35 U.S.C. 103 as being unpatentable over Fellstrom (“Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial.” The Lancet 389.10084 (2017): 2117-2127) in view of Calliditas Therapeutics (“Pharmalink’s core patents for Nefecon® treatment for renal disease granted in United States, Europe, China and Hong Kong.” 2014 July 10. [Press Release]), Watts (US 8,491,932 B2), Villa (US 9,192,581 B2), and Gareb 2016 (“Development of a zero-order sustained-release tablet containing mesalazine and budesonide intended to treat the distal gastrointestinal tract in inflammatory bowel disease.” European Journal of Pharmaceutics and Biopharmaceutics 103 (2016): 32-42).
Fellstrom is directed to: “Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial.” Title.
Fellstrom discloses that “[p]rimary IgA nephropathy is the most prevalent chronic glomerular disease worldwide, with patients often diagnosed as young adults.” Page 2117, left column.
Fellstrom discloses: “A novel, oral, targeted-release formulation of the glucocorticosteroid budesonide (TRF-budesonide; Nefecon [Pharmalink AB, Stockholm, Sweden]) was developed to release the drug in the distal ileum, which has a high density of Peyer’s patches.” Page 2118, left column.
Fellstrom discloses: “Trial medication was an oral capsule formulation of TRF-budesonide (Nefecon) or placebo, designed to provide sustained release of active compound that was delayed until the capsule reached the distal ileum, targeting the site with a high density of Peyer’s patches.” (Emphasis added) Page 2119, right column. “The safety profile of TRF-budesonide was anticipated to be superior to high dose systemic corticosteroids because of its extensive first-pass metabolism—less than 10% of budesonide enters systemic circulation.” (Emphasis added) Page 2118 at sentence bridging left/right columns.
Fellstrom discloses: “Patients were stratified according to their baseline UPCR (≤0·9 g/g and >0·9 g/g) at month 0 (baseline). We randomly allocated patients to treatment groups using a computer algorithm method of permuted blocks. Within each block, patients were allocated in a 1:1:1 ratio to 16 mg/day TRF-budesonide, 8 mg/day TRF-budesonide, or placebo.” (Emphasis added) Page 2119, left column.
Fellstrom discloses: “To ensure masking, placebo capsules provided by the sponsor had the same appearance and route of administration as the active capsules. Patients self-administered masked capsules, once daily, 1 h before breakfast during the treatment phase. During follow-up (months 9–12), patients who received 16 mg/day TRF-budesonide during months 0–9 were tapered to 8 mg/day for 2 weeks while all other patients (ie, those who received TRF-budesonide 8 mg/day or placebo during months 0–9) received placebo to maintain masking. No further trial medication was administered after tapering.” (Emphasis added) Page 2119 at paragraph bridging left/right columns.
Fellstrom discloses: “This trial showed that 9 months’ treatment with TRF-budesonide resulted in reduced proteinuria and stabilised eGFR in patients with IgA nephropathy at risk of progression to end-stage renal disease. The observed effect was additive to optimised RAS blockade and supports the use of TRF-budesonide as adjunct therapy in patients with IgA nephropathy with persistent proteinuria. TRF-budesonide has the potential to become the first disease-specific treatment for IgA nephropathy, with a risk-benefit profile supportive of its use early in the course of disease.” Page 2126, right column. “At 9 months, mean UPCR [urine protein creatinine ratio] had decreased by 27.3% in 48 patients who received 16 mg/day (0.71; 0.53–0.94; p=0.0092) and 21.5% in the 51 patients who received 8 mg/day (0.76; 0.58–1.01; p=0.0290); 50 patients who received placebo had an increase in mean UPCR of 2.7%.” (Emphasis added) Abstract.
Although Fellstrom discloses that TRF-budesonide (Nefecon®) provides sustained release of active compound that is delayed until the capsule reaches the distal ileum (page 2118), Fellstrom is silent as to whether Nefecon® can be formulated as a tablet, rather than a capsule. Consequently, Fellstrom does not satisfy claim 2 of the present application. As explained below, the following four references — in combination — compensate for this deficiency: Calliditas Therapeutics, Watts, Villa, and Gareb 2016.
Calliditas Therapeutics is a press release directed to the core patents for Nefecon®.
Calliditas Therapeutics teaches: “Nefecon is a potential disease-modifying treatment for patients with primary lgA nephropathy at risk of developing end-stage renal disease.” Page 1.
Calliditas Therapeutics teaches: “The patents issued in the US (US 8,491,932), Europe (EP 2278958) China (200980127272.5) and Hong Kong (1158510) provide protection around the formulation of Nefecon and its use as a treatment of glomerulonephritis, including IgA nephropathy, the most common form of primary glomerulonephritis and a cause of end-stage renal disease.” (Emphasis added) Page 1.
Watts, which is US 8,491,932, is directed to compositions for the oral delivery of corticosteroids.
Watts teaches: “For glomerulonephritis, a suitable profile would be for significant drug release to begin in the ileum and to continue for from about 2 to 6 hours or so that drug release occurs predominately in the lower third of the small intestine and the upper quarter of the large intestine.” (Emphasis added) Column 3, lines 43-48.
In Example 2 (column 11), Watts teaches an enterically-coated capsule containing the sustained-release budesonide beads of Example 1. More specifically, section (b) of Example 2 teaches that the capsule is coated with a solution comprising Eudragit® L100 copolymer and Eudragit® S100 copolymer (Degussa, Darmstadt, Germany). Column 11, lines 52-56. Those are enteric (gastroresistant) copolymers. Column 9, lines 20-25; column 8, 62-68; and column 1, lines 41-44. The enterically-coated capsules of Example 2 “are suitable for use in the treatment of glomerulonephritis.” (Emphasis added) Column 12, lines 1-2.
Watts additionally teaches: “Tablets may be prepared by compressing a blend of individual ingredients or by compressing granules or a blend of granules comprising some of the ingredients. Typical inert ingredients used in tablets include, but are not limited to, diluents such as lactose, microcrystalline cellulose, dextrose, dextrin, starches and dibasic calcium phosphate; binders such as povidone, pregelatinised starch and hydroxypropyl methylcellulose; glidants such as talc and silicon dioxide; lubricants such as hydrogenated vegetable oil and stearic acid and its salts.” (Emphasis added) Column 6, lines 9-19.
The examiner notes that a person having ordinary skill in the art, following a review of Watts, would have readily envisaged formulating a budesonide tablet for the treatment of glomerulonephritis that comprises the ileum-targeting enteric coating of Example 2. MPEP § 2131.02(III) (“A reference disclosure can anticipate a claim when the reference describes the limitations but ‘d[oes] not expressly spell out’ the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.”), quoting Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015).
Villa is directed to an enterically-coated budesonide tablet, which is referred to therein as budesonide-MMXTM. Column 19 at claim 1; see also column 7, lines 61-65, and column 12, lines 65-67.
Villa teaches how to manufacture a tablet core that comprises budesonide. Column 13, lines 10-54 (Examples 1-2); see also column 4, lines 65-67 (discussing compression).
Gareb 2016 is directed to a zero-order sustained-release tablet having a newly-developed tablet core that comprises budesonide. Title/Abstract.
Gareb 2016 teaches that budesonide-MMXTM is marketed under the tradename Cortiment®. Page 33, right column.
Gareb 2016 teaches: “The in vitro results of the present study show that budesonide from Cortiment® 9 mg is not readily released in the aqueous phase of the GISS. This suggests that the effectiveness of Cortiment® 9 mg may be improved if budesonide release in the aqueous phase would be increased, since it is expected that only the dissolved and from the tablet liberated fraction is able to treat the inflamed loci. The C[4.92] formulation in this present study contains hardly any fatty components that may act as a sink, preventing budesonide release, and showed eleven times (77% vs. 7%) more budesonide release in the aqueous phases of the GISS.” Page 39, left column (emphasis added).
Gareb 2016 teaches: “[T]he C[4.92] [formulation] could be used as a platform technology for the development of new oral zero-order sustained-release dosage forms containing only mesalazine or budesonide that can be applied in the treatment of ileo-colonic CD and UC in which single-drug treatment is appropriate or when a different daily dose of just one drug is desired during combination treatment.” Page 40 at Section 4; see also Abstract (“The in vitro results suggest that MMX®-budesonide effectiveness may be improved if budesonide release in the aqueous phase would be increased and that C[4.92] is a potential, new treatment option for ileo-colonic CD and UC.”).
Gareb 2016 teaches that the new-developed core of the C[4.92] tablet comprises: budesonide, HPMC (gelling matrix material), and croscarmellose sodium (disintegrant). Pages 36-37 at Section 3.2; page 34 at Table 2 and Section 2.3.
Gareb 2016 teaches that HPMC (hydroxypropyl methylcellulose) is a “matrix former in oral controlled-release dosage forms” and “[u]pon contact with water, the HPMC polymer starts to hydrate resulting in the formation of a viscous gel around the dosage form.” Page 33, right column (emphasis added). “Subsequently,” Gareb 2016 continues, “drug dissolution is governed by its diffusion through the gel layer and the gradual erosion of the gel matrix, resulting in drug release in a controlled manner.” Id. (emphasis added).
Before the effective filing date of the claimed invention, the teachings of Calliditas Therapeutics, Watts, Villa, and Gareb 2016 would have motivated a person having ordinary skill in the art to modify Fellstrom by (i) formulating a tablet comprising the budesonide core of Gareb 2016 and the ileum-targeting enteric coating of Example 2 of Watts and, thereafter, (ii) orally administering the resulting enterically-coated budesonide tablet to a patient suffering from IgA nephropathy. This modification would have been made with a reasonable of success, especially considering that (1) the gel-matrix tablet core of Gareb 2016 enhances the bioavailability of budesonide in the ileum, (2) the enteric coating of Watts is formulated specifically for the treatment of glomerulonephritis, and (3) primary IgA nephropathy is the most prevalent chronic glomerular disease worldwide, as disclosed on page 2117 of Fellstrom. Therefore, claims 2, 11, and 24 are prima facie obvious. MPEP § 2143.02(I) (“Where there is a reason to modify or combine the prior art to achieve the claimed invention, the claims may be rejected as prima facie obvious provided there is also a reasonable expectation of success.”).
Regarding claims 4 and 5, Villa teaches that the enteric coating is 11.8 wt% of the total budesonide tablet (40 mg/340 mg). Column 13 at Example 2. Additionally, Watts teaches that an enteric coating layer of about 6 to 10 mg/cm2 is generally suitable for the treatment of glomerulonephritis. Column 9, lines 49-51. Applicant is alerted that “‘[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.’” MPEP § 2144.05(II)(A), quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Regarding claim 6, Applicant is referred to Section 2.5 of Gareb 2016 (page 34).
Regarding claims 7-9, Villa teaches that the lubricant (magnesium stearate) is 0.88 wt% of the total budesonide tablet (3 mg/340 mg). Column 13 at Example 2. Applicant is additionally referred to Section 2.3 and Table 2 of Gareb 2016 (page 34), which teaches sodium stearyl fumarate.
Regarding claims 12 and 13, Applicant is referred to Table 2 of Gareb 2016 (page 34), which teaches 1.5 wt% croscarmellose sodium.
Regarding claim 14, Villa teaches the core of the budesonide tablet is granulated. Column 13, lines 15-20 (Example 1). Applicant is additionally referred to Sections 2.3 and 2.4 of Gareb 2016 (page 34).
Regarding claims 15-18, Villa teaches that the fillers (microcrystalline cellulose and lactose monohydrate) are 61 wt% of the total budesonide tablet ((156+50 mg)/340 mg). Column 13 at Example 2; see also MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”) and (“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”). Applicant is additionally referred to Section 2.3 and Table 2 of Gareb 2016 (page 34), which discloses microcrystalline cellulose (MC).
Regarding claims 19-22, Villa teaches that the binder (low viscosity hydroxypropyl cellulose) is 17.6 wt% of the total budesonide tablet (60 mg/340 mg). Column 13 at Examples 1 and 2; see also MPEP § 2144.05(I) (“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”).
Regarding claims 25 and 26, Applicant is referred to Table 2 of Gareb 2016 (page 34), which teaches 10 wt% HPMC. MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”) and (“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”).
Regarding claims 27 and 28, Villa teaches that the core of the budesonide tablet comprises lactose monohydrate, which is a water-soluble filler. Column 13 at Example 2.
Regarding claims 29 and 30, Watts teaches that each oral unit dosage form of Example 2 comprises 4 mg of budesonide. Column 11, lines 48-50. Applicant is additionally referred to Table 2 of Gareb 2016 (page 34), which teaches 9 mg of budesonide.
Regarding claims 31 and 32, Applicant is referred to Watts at column 3, lines 60-66, where the desired release profile for treatment of glomerulonephritis is set forth.
Claim Rejections - Double Patenting (Non-Statutory)
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 obviousness-type 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR1.321(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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 2, 4-9, 11-22, and 24-32 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-31 of co-pending Application No. 19/194,972 (as amended on December 29, 2025) in view of Villa (US 9,192,581 B2) and Gareb 2016 (“Development of a zero-order sustained-release tablet containing mesalazine and budesonide intended to treat the distal gastrointestinal tract in inflammatory bowel disease.” European Journal of Pharmaceutics and Biopharmaceutics 103 (2016): 32-42).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 2 of the ’972 Application is directed to a method of treating IgA nephropathy by orally administering, at a dosage of “about 16 mg,” a budesonide formulation that is substantially similar to the formulation recited in claim 2 of the present application. Conflicting claims 3 and 4 disclose that the budesonide formulation is in the form of an enterically-coated tablet, and conflicting claims 15-16 disclose that the tablet can comprise HPC or HPMC. Conflicting claim 23 discloses that each unit dosage form comprises about 4 mg budesonide, and conflicting claim 24 discloses the release profile recited in present claim 31. The teachings of Villa and Gareb 2016, which are discussed above in the §103 rejection and are incorporated by reference into this rejection, compensate for any deficiencies in the conflicting claims in relation to the compositional profile of the tablet recited in the dependent claims of the present application. Therefore, the present claims are not patentably distinguishable over conflicting claims 2-31 of the ’972 Application. This is a provisional rejection because the conflicting claims have not been patented.
Claims 2, 4-9, 11-22, and 24-32 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-31 of co-pending Application No. 19/242,380 (as amended on December 24, 2025) in view of Villa (US 9,192,581 B2) and Gareb 2016 (“Development of a zero-order sustained-release tablet containing mesalazine and budesonide intended to treat the distal gastrointestinal tract in inflammatory bowel disease.” European Journal of Pharmaceutics and Biopharmaceutics 103 (2016): 32-42).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 2 and 15 of the ’380 Application are directed to a method of treating IgA nephropathy by orally administering, at a dosage of “about 16 mg,” an enteric budesonide formulation that is substantially similar to the formulation recited in claim 2 of the present application. Conflicting claim 16 discloses that the budesonide formulation is in the form of a tablet, and conflicting claims 14-15 disclose a release profile that targets the ileum. Conflicting claims 9-10 and 28 disclose that the tablet can comprise HPC or HPMC. The teachings of Villa and Gareb 2016, which are discussed above in the §103 rejection and are incorporated by reference into this rejection, compensate for any deficiencies in the conflicting claims in relation to the compositional profile of the tablet recited in the dependent claims of the present application. Therefore, the present claims are not patentably distinguishable over conflicting claims 2-31 of the ’380 Application. This is a provisional rejection because the conflicting claims have not been patented.
Claims 2, 4-9, 11-22, and 24-32 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-31 of co-pending Application No. 19/303,799 (as amended on September 25, 2025) in view of Villa (US 9,192,581 B2) and Gareb 2016 (“Development of a zero-order sustained-release tablet containing mesalazine and budesonide intended to treat the distal gastrointestinal tract in inflammatory bowel disease.” European Journal of Pharmaceutics and Biopharmaceutics 103 (2016): 32-42).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 2 of the ’799 Application is directed to a method of treating IgA nephropathy by orally administering, at a dosage of “about 16 mg,” an enterically-coated budesonide formulation that targets the ileum and is substantially similar to the formulation recited in claim 2 of the present application. Conflicting claim 7 discloses that the budesonide formulation is in the form of a tablet, and conflicting claims 22-23 disclose that the tablet can comprise HPC or HPMC. Conflicting claim 30 discloses that each unit dosage form comprises about 4 mg budesonide, and conflicting claim 31 discloses the release profile recited in present claim 31. The teachings of Villa and Gareb 2016, which are discussed above in the §103 rejection and are incorporated by reference into this rejection, compensate for any deficiencies in the conflicting claims in relation to the compositional profile of the tablet recited in the dependent claims of the present application. Therefore, the present claims are not patentably distinguishable over conflicting claims 2-31 of the ’799 Application. This is a provisional rejection because the conflicting claims have not been patented.
Conclusion
Claims 2, 4-9, 11-22, and 24-32 are rejected.
No claim is allowed.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
14 May 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
Prosecution Insights