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.
The Patent Office has transferred this application to a different examiner. Please direct any reply to the examiner now identified on the cover page.
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 10 November 2025, Applicant amended claims 1 and 21. Additionally, Applicant cancelled claims 17-18 and 40-41. Claims 1-16, 19-39, and 42-43 are pending.
Status of the Rejections and Objections
All rejections set forth in the previous Office action (13 August 2025) are withdrawn.
All rejections and objections set forth in this Office action are new.
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 6 and 29 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 6 and 29, the following limitation is unclear: “coalescable polymers.” Persons of ordinary skill in the art can reasonably disagree over which polymers qualify as “coalescable” and, conversely, which do not. Where is the boundary between coalescable polymers and non-coalescable polymers? Moreover, what is the protocol for determining whether a polymer is coalescable? The specification does not provide guidance on these issues and, therefore, fails to clarify the claims. 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)”).
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 1-16, 19-39, and 42-43 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 & SA1-SA27) 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, optionally, Thompson (“Proteinuria reduction as a surrogate end point in trials of IgA nephropathy.” CJASN 14.3 (2019): 469-481) and/or Ulmius (US 5,643,602).
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. This rejection contains citations to the primary article (pages 2117-2127), as well as citations to the Supplementary Appendix, which are in the following format: SA[page number].
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.” (Emphasis added) Page 2119 at paragraph bridging left/right columns.
Fellstrom discloses: “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy, and time-averaged proteinuria is predictive of renal survival in these patients—the rate of decline of renal function and subsequent risk of renal failure are associated with higher levels of time-averaged proteinuria.” (Emphasis added) Page 2125, left column; see also page 2126, left column (“Proteinuria is a major risk factor for renal failure in IgA nephropathy.”).
Fellstrom discloses: “Patients entering the treatment phase of this trial were at risk of progression to end-stage renal disease due to persistent proteinuria despite optimised RAS blockade. The further reduction in proteinuria was achieved by targeting an alternative pharmacological mechanism, using TRF-budesonide, irrespective of baseline UPCR, eGFR, and time since diagnosis of IgA nephropathy (appendix). Our findings support the generally accepted hypothesis that mucosal immune system dysfunction has a significant role in the pathogenesis of IgA nephropathy because TRF-budesonide targets the region of the gastrointestinal tract where Peyer’s patches reside at high density.” (Emphasis added) Pages 2124-2125, bridging paragraph. “The analysis suggested that an improvement in proteinuria at 9 months for a drug compared with control would be positively associated with an improvement in longer term end-stage renal disease outcome.” Page 2125, left column. “For patients in the 16 mg/day TRF-budesonide group, proteinuria in the form of UPCR and 24-h urine protein excretion both decreased by about 30%, compared with the placebo-treated group.” Page 2125, left column.
Fellstrom teaches: “Panel A [of Figure S1] shows UPCR change at 9 months vs. baseline UPCR for TRF-budesonide-treated patients (solid line) and placebo-treated patients (dashed line) with the 95% confidence intervals. Parallel lines indicate a constant effect of TRF-budesonide on the relative change in UPCR regardless of baseline UPCR level (p=0·8006 for treatment by baseline interaction).” (Emphasis added) Page SA14. Panel A (page SA15) is shown below:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
Panel A of Figure S1 shows budesonide therapy is beneficial at a baseline UPCR range of 0.250 to 4.000, which is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”).
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 “extended-release excipient” and an “enteric coating.” Consequently, Fellstrom does not satisfy claim 1 or 21 of the present application. As explained below, the following two references — in combination — compensate for those deficiencies: 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.
Section (iv) of Example 1 of Watts (columns 10-11) teaches budesonide cores that are coated with a controlled-release (extended-release) layer comprising a blend of a water-insoluble polymer (ethylcellulose) and pore-forming 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/coalescing the extended-release layer. The examiner’s position is supported by page 52 of Applicant’s specification, as originally filed, which states: “Spraying at a temperature towards the upper end of this region, such as about 50 to about 65°C may avoid the requirement of a separate curing/coalescing step as outlined below.” Para. [0268]. This observation provides supplementary support for the examiner’s position that the release profile functional limitations recited in the claims of the present application are satisfied, as discussed in more detail later in this Office action (see para. [34]).
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 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.” Column 12, lines 1-2. Budesonide is the only active pharmaceutical ingredient in those capsules. The examiner notes that Immunoglobulin A (IgA) nephropathy, commonly referred to as Berger disease, has been widely recognized as the most common form of primary glomerulonephritis worldwide since at least as early as the effective filing date of the present application (see Fellstrom at page 2117, left column).
Before the effective filing date of the claimed invention, the foregoing teachings of Calliditas Therapeutics and Watts — in combination — 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 who has a baseline UPCR of 0.250 – 4.000. 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.
Applicant is referred to Watts at column 3, lines 60-66, where the desired release profile for treatment of glomerulonephritis is set forth. Watts additionally 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. Applicant is alerted that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP § 2112.01(I), citing In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
The first optional reference (Thompson), which published approximately two years after Fellstrom, teaches that “epidemiologic data indicate a strong and consistent relationship between the level and duration of proteinuria and loss of kidney function in patients with IgAN.” (Emphasis added) Page 477, right column; see also Table 4. “Trial-level analyses of data from 13 randomized, controlled trials also show an association between treatment effects on proteinuria and treatment effects on a composite of the time to the first occurrence of a doubling of serum creatinine level, ESKD, or death.” Page 477, right column. “These data support the use of proteinuria reduction as a reasonably likely surrogate end point for a treatment’s effect on the loss of kidney function and progression to ESKD in future trials enrolling a similar population.” Id. Table 2 of Thompson teaches that UPCR is used to measure proteinuria. Pages 472-473. The examiner notes that Thompson is applied as an optional reference because it reinforces the teachings of Fellstrom.
In sum, claims 1-14, 21-24, and 29-37 are prima facie obvious.
Regarding claims 15 and 38, 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 claims 16, 19-20, 39 and 42-43, the claimed features are merely expressions of various intended results of engaging in the active (manipulative) steps of the method of treatment recited in claim 1 or 21 and, therefore, are not afforded patentable weight. MPEP § 2111.04(I) (a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited’”), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003). In other words, none of these claims requires a manipulative difference over the prior art, as applied above to claims 1 and 21.
Regarding claims 25 and 26, the polymer blend of the controlled-release layer of Section (iv) of Example 1 of Watts comprises about 83 wt% ethylcellulose (225/270 grams) and about 17 wt% water-soluble (pore-forming) polymers HPMC/PEG (45/270 grams). MPEP § 2144.05(I) (overlapping, approaching, and similar ranges, amounts, and proportions).
Regarding claims 27 and 28, Watts discloses that 4 kg of budesonide cores are coated with 778 g of the extended-release polymeric blend (ethylcellulose/HPMC/PEG). Column 11, lines 22-38. The calculation of 778 g / (778 g + 4,000 g) yields a weight percentage of 16.3%, which seemingly lies inside — or is close to — the concentration ranges recited respectively in claims 27 and 28. MPEP § 2144.05(I) (overlapping, approaching, and similar ranges, amounts, and proportions). In the alternative, Ulmius (the second optional reference) teaches a corresponding range of between 0.5% and 30% by weight, preferably between 1% and 15% (column 5, lines 59-61 and 28-33), thereby compensating for any deficiency in Watts. 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.”). Applicant is additionally referred to Ulmius at claim 21 (“The formulation according to claim 1, 2 or 3, wherein the layer comprises between 1% and 15% (w/w) of the total weight of the coated pellet.”) and at Section (ii)(b) of claim 1, which is located at column 14, lines 15-24.
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 1-16, 19-39, and 42-43 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 7-26 of Patent No. 11,896,719 (issued 13 February 2024) 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 & SA1-SA27).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 7 of the ’719 Patent 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 claims 1 and 21 of the present application. The remaining conflicting claims (i.e., claims 8-26) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 1-16, 19-20, 22-39, and 42-43. However, the conflicting claims are silent regarding the baseline UPCR of the subject. Fellstrom teaches (i) “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy” (page 2125, left column) and (ii) budesonide therapy is beneficial at a baseline UPCR of 0.250–4.000 (Figure S1 at Panel A). That UPCR range is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”). Therefore, the present claims are not patentably distinguishable over conflicting claims 7-26 of the ’719 Patent.
Claims 1-16, 19-39, and 42-43 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of Patent No. 12,171,882 (issued 24 December 2024) 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 & SA1-SA27).
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, at a dosage of “about 16 mg,” a budesonide formulation that is substantially similar to the formulation recited in claims 1 and 21 of the present application. The remaining conflicting claims (i.e., claims 2-15 and 17-30) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 1-16, 19-20, 22-39, and 42-43. However, the conflicting claims are silent regarding the baseline UPCR of the subject. Fellstrom teaches (i) “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy” (page 2125, left column) and (ii) budesonide therapy is beneficial at a baseline UPCR of 0.250–4.000 (Figure S1 at Panel A). That UPCR range is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”). Therefore, the present claims are not patentably distinguishable over conflicting claims 1-30 of the ’882 Patent.
Claims 1-16, 19-39, and 42-43 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 18-30 of Patent No. 12,311,057 (issued 27 May 2025) 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 & SA1-SA27).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 18 of the ’057 Patent 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 claims 1 and 21 of the present application. The remaining conflicting claims (i.e., claims 19-30) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 1-16, 19-20, 22-39, and 42-43. However, the conflicting claims are silent regarding the baseline UPCR of the subject. Fellstrom teaches (i) “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy” (page 2125, left column) and (ii) budesonide therapy is beneficial at a baseline UPCR of 0.250–4.000 (Figure S1 at Panel A). That UPCR range is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”). Therefore, the present claims are not patentably distinguishable over conflicting claims 18-30 of the ’057 Patent.
Claims 1-16, 19-39, and 42-43 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-12, 14, 17-28, and 30-31 of co-pending Application No. 19/194,972 (as amended on 06 July 2026) 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 & SA1-SA27).
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 daily dosage of about 16 mg,” a budesonide formulation that is substantially similar to the formulation recited in claims 1 and 21 of the present application. The remaining conflicting claims (i.e., claims 3-12, 14, 17-28, and 30-31) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 1-16, 19-39, and 42-43. However, the conflicting claims are silent regarding the baseline UPCR of the subject. Fellstrom teaches (i) “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy” (page 2125, left column) and (ii) budesonide therapy is beneficial at a baseline UPCR of 0.250–4.000 (Figure S1 at Panel A). That UPCR range is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”). Therefore, the present claims are not patentably distinguishable over conflicting claims 2-12, 14, 17-28, and 30-31 of the ’972 Application. This is a provisional rejection because the conflicting claims have not been patented.
Claims 1-16, 19-39, and 42-43 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 29 December 2025) 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 & SA1-SA27).
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 claims 1 and 21 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 1-16, 19-39, and 42-43. However, the conflicting claims are silent regarding the baseline UPCR of the subject. Fellstrom teaches (i) “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy” (page 2125, left column) and (ii) budesonide therapy is beneficial at a baseline UPCR of 0.250–4.000 (Figure S1 at Panel A). That UPCR range is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”). 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 1-16, 19-39, and 42-43 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 09 July 2026) 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 & SA1-SA27).
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 claims 1 and 21 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 1-16, 19-39, and 42-43. However, the conflicting claims are silent regarding the baseline UPCR of the subject. Fellstrom teaches (i) “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy” (page 2125, left column) and (ii) budesonide therapy is beneficial at a baseline UPCR of 0.250–4.000 (Figure S1 at Panel A). That UPCR range is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”). 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 1-16, 19-39, and 42-43 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-3, 5-8, 11-19, 21, and 24-31 of co-pending Application No. 19/303,799 (as amended on 07 July 2026) 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 & SA1-SA27).
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 administering, at a dosage of “about 16 mg per day,” a budesonide formulation that is substantially similar to the formulation recited in claims 1 and 21 of the present application. The remaining conflicting claims (i.e., claims 3, 5-8, 11-19, 21, and 24-31) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 1-16, 19-39, and 42-43. However, the conflicting claims are silent regarding the baseline UPCR of the subject. Fellstrom teaches (i) “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy” (page 2125, left column) and (ii) budesonide therapy is beneficial at a baseline UPCR of 0.250–4.000 (Figure S1 at Panel A). That UPCR range is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”). Therefore, the present claims are not patentably distinguishable over conflicting claims 2-3, 5-8, 11-19, 21, and 24-31 of the ’799 Application. This is a provisional rejection because the conflicting claims have not been patented.
Claims 1-16, 19-39, and 42-43 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 2, 4-9, 11-22, and 24-32 of co-pending Application No. 19/304,103 (as amended on 28 April 2026) 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 & SA1-SA27).
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 claims 1 and 21 of the present application. The remaining conflicting claims (i.e., claims 4-9, 11-22, and 24-32) collectively recite limitations that satisfy or overlap the corresponding limitations recited in present claims 2-29. However, the conflicting claims are silent regarding the baseline UPCR of the subject. Fellstrom teaches (i) “Evidence and general acceptance is increasing that a reduction in proteinuria is associated with a reduced risk of end-stage renal disease in patients with IgA nephropathy” (page 2125, left column) and (ii) budesonide therapy is beneficial at a baseline UPCR of 0.250–4.000 (Figure S1 at Panel A). That UPCR range is overlapped by the corresponding range of “≥ 1.5 g/g” recited in claims 1 and 21 of the present application. 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.”). Therefore, the present claims are not patentably distinguishable over conflicting claims 2, 4-9, 11-22, and 24-32 of the ’103 Application. This is a provisional rejection because the conflicting claims have not been patented.
Conclusion
Claims 1-16, 19-39, and 42-43 are rejected.
The title is objected to.
No claim is allowed.
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.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
/P.A./
14 August 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
Prosecution Insights