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 first 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 Preliminary Amendment filed 25 September 2025, Applicant cancelled claim 1 and added thirty new claims, i.e., claims 2-31. Claims 2-31 are pending.
Objection to the Specification
The title of the invention (“Pharmaceutical Compositions”) is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. MPEP § 606.01. The following title is suggested: “Method of treating IgA nephropathy.”
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.
Claims 2-31 are 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.
Regarding claims 2, 7, and 30, the recited dose of “about 16 mg of budesonide” is not accompanied by a temporal limitation, such as “daily” or “per day.” This results in ambiguity because the claim encompasses divided doses. For example, is the dose limitation of claim 2 satisfied if a patient takes two capsules that each comprise 4 mg of budesonide on Monday, and the following day (Tuesday) takes another two capsules that each comprise 4 mg budesonide, for a total of 16 mg budesonide? Instead, what if the second group of two 4 mg capsules is taken four hours later on that same Monday? Does that satisfy claim 2? This ambiguity renders claim 2 and all claims depending thereon indefinite. MPEP § 2173.04 (“a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim)”). Applicant is additionally referred to claim 7 (“wherein the composition is in the form of one or more capsules or tablets”) and claim 30 (“wherein each pharmaceutical composition comprises about 4 mg of budesonide”), both of which are similarly ambiguous.
Regarding claim 3, the following limitation is unclear: “wherein the release is predicted by an in vitro/in vivo correlation (IVIVC).” How does the prediction concerning the release profile further define the actual compositional or structural profile of the pharmaceutical composition? Isn’t a prediction essentially a mental step?
Regarding claim 4, the following limitation is unclear: “wherein the IVIVC physiologically based pharmacokinetic model used to predict the release is carried out using GastroPlus® software version 9.8.3002.” Again, how does the prediction concerning the release profile further define the actual compositional or structural profile of the pharmaceutical composition? Isn’t a prediction essentially a mental step? Furthermore, the trademark GastroPlus® renders the claim indefinite. MPEP § 2173.05(u) (“If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.”).
Regarding claim 6, the ratios “1:1, and 1:2” dangling at the end of the claim are unclear. What do they correspond to?
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 2-31 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]) and Watts (US 8,491,932 B2).
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 includes “an enteric coating.” Consequently, Fellstrom does not satisfy claim 2 of the present application. As explained below, the following two references — in combination — compensate for this deficiency: Calliditas Therapeutics and Watts.
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.
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. Watts even teaches that the enterically-coated capsules of Example 2 “are suitable for use in the treatment of glomerulonephritis.” Column 12, lines 1-2.
Before the effective filing date of the claimed invention, the teachings of Calliditas Therapeutics would have motivated a person having ordinary skill in the art to modify Fellstrom by orally administering the enteric budesonide capsules of Example 2 of Watts to a patient suffering from IgA nephropathy. The foregoing modification would have been made with a reasonable expectation of success in treating IgA nephropathy because Example 2 is essentially identified as Nefecon® (TRF-budesonide) in Calliditas Therapeutics, especially considering no other exemplary budesonide formulation in final form (i.e., ready or otherwise intended for administration to the patient) is disclosed in Watts. Therefore, claims 2-4, 7-8, and 11 are prima facie obvious.
Regarding claims 5 and 6, Watt teaches: “Commercial sources of methacrylic acid-methyl methacrylate copolymer (1:1) and methacrylic acid-methyl methacrylate copolymer (1:2) are Eudragit® L100 copolymer and Eudragit® S100 copolymer respectively (Degussa, Germany).” Column 9, lines 21-25; see also Section (b) of Example 2.
Regarding claims 9-10, 12-16, 20-23 and 25, Applicant is referred to Example 1 of Watts (columns 10-11), which in Section (iv) thereof teaches that the budesonide beads are coated with a controlled-release layer comprising a blend of water-insoluble polymers (ethylcellulose) and water-soluble polymers (HPMC/PEG). More specifically, Watts teaches:
900 g of Surelease® dispersion (ethylcellulose aqueous dispersion, 25% by weight solids) was transferred to a beaker. 45 g of Opadry® coating material (hydroxypropyl methylcellulose/polyethylene glycol blend) was dissolved in 555 g of water and the resulting solution gently mixed into the Surelease® dispersion.
4 kg of the coated beads (obtained in step (iii)) were transferred into the coating chamber of the MP-1 coater which was set up with the following parameters:
Fluidisation air volume=80 m3/h
Inlet temp=70° C.
Atomisation pressure=29 psi (2 bar)
778 g of coating dispersion was applied to the beads at an approximate rate of 9 g/min. The coated beads were dried while being fluidised for 15 minutes at 60° C. followed by 15 minutes at 30° C.
Column 11, lines 22-38.
The examiner notes that drying in a fluidized bed for 15 minutes at 60°C (equivalent to 140°F) qualifies as curing. MPEP 2111 (“During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”). In further regard to claims 13-16, the polymer blend of the controlled-release layer of Section (iv) of Example 1 comprises about 83 wt% ethylcellulose (225/270 grams) and about 17 wt% water-soluble polymers HPMC/PEG (45/270 grams). MPEP § 2144.05(I) (overlapping, approaching, and similar ranges, amounts, and proportions).
Regarding claims 17-19, Watts teaches: “The rate-controlling material is preferably present in the sustained release component in an amount of from about 0.25 to about 15% by weight of the sustained release component, more preferably from about 0.5 to about 12% by weight and most preferably from about 1 to about 10% by weight.” Column 8, lines 11-16; see also column 8, lines 17-20 (defining ethylcellulose as a “rate-controlling material”) and 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.”).
Regarding claim 24, Watts teaches: “To provide delayed release of the sustained release component either the sustained release component or the capsule in which it is contained is treated, for example coated, with a material that substantially prevents release of the sustained release component until the composition reaches the intestine, for example the lower small intestine.” Column 8, lines 52-57.
Regarding claims 26-28, Watts teaches: “Expressed as mg of coating per cm2 of surface area, the amount of delayed release coating on a capsule or the sustained release component is preferably from about 1 to about 30 mg/cm2, more preferably from about 2 to about 25 mg/cm2 and most preferably from about 3 to about 20 mg/cm2. Thus, a capsule with a surface area of about 5 cm2 most preferably contains from about 15 to about 100 mg of coating.” (Emphasis added) Column 9, lines 39-45; see also column 9, lines 49-51 (“a coating layer of from about 6 to 10 mg/cm2 may be suitable for a dosage form intended for use in the treatment of glomerulonephritis”) and 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.”).
Regarding claim 29, Example 2 of Watts uses size 0 capsules (column 11, lines 46-48), which are close enough to size 1 capsules to support a finding of prima facie obviousness. 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 claim 30, Watts teaches that each capsule of Example 2 comprises 4 mg of budesonide. Column 11, lines 48-50.
Regarding claim 31, 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 2-31 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-26 of Patent No. 11,896,719.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 1 and 7 of the ’719 Patent are directed to a method of treating IgA nephropathy by administering, at a daily dosage of 16 mg, a budesonide formulation that is substantially similar to the formulation recited in claim 2 of the present application. The remaining conflicting claims (i.e., claims 2-6 and 8-26) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 3-31. Therefore, the present claims are not patentably distinguishable over conflicting claims 1-26 of the ’719 Patent.
Claims 2-31 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of Patent No. 12,171,882 in view of 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).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 1 and 16 of the ’882 Patent are directed to a method of treating IgA nephropathy by administering a budesonide formulation that is substantially similar to the formulation recited in claim 2 of the present application. The remaining conflicting claims (i.e., claims 2-15 and 17-30) collectively recite limitations that satisfy or overlap the compositional limitations recited in the present claims. Although the conflicting claims are silent regarding the dosage of budesonide, Fellstrom teaches a corresponding dosage of 16 mg/day and, thereby, compensates for that deficiency. Thus, the present claims are not patentably distinguishable over conflicting claims 1-30 of the ’882 Patent.
Claims 2-31 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of Patent No. 12,311,057.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 1 and 18 of the ’057 Patent are directed to a method of treating IgA nephropathy by administering, at a daily dosage of 16 mg, a budesonide formulation that is substantially similar to the formulation recited in claim 2 of the present application. The remaining conflicting claims (i.e., claims 2-17 and 19-30) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 3-31. Therefore, the present claims are not patentably distinguishable over conflicting claims 1-30 of the ’057 Patent.
Claims 2-31 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 August 22, 2025).
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 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. The remaining conflicting claims (i.e., claims 3-31) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 3-31. 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 2-31 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-29 of co-pending Application No. 19/242,077 (as amended on September 18, 2025).
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 ’077 Application is directed to a method of treating IgA nephropathy by administering, at “a daily dosage of about 16 mg,” a budesonide formulation that is substantially similar to the formulation recited in claim 2 of the present application. The remaining conflicting claims (i.e., claims 3-29) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 3-31. Therefore, the present claims are not patentably distinguishable over conflicting claims 2-29 of the ’077 Application. This is a provisional rejection because the conflicting claims have not been patented.
Claims 2-31 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).
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 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. The remaining conflicting claims (i.e., claims 3-31) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 3-31. 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 2-31 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-31 of co-pending Application No. 19/304,103 (as amended on September 25, 2025).
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 ’103 Application is directed to a method of treating IgA nephropathy by 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. The remaining conflicting claims (i.e., claims 3-31) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 3-31. Therefore, the present claims are not patentably distinguishable over conflicting claims 2-31 of the ’103 Application. This is a provisional rejection because the conflicting claims have not been patented.
Conclusion
Claims 2-31 are rejected.
The title is objected to.
No claim is allowed.
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/P.A./
03 January 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611