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 third 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.
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission, which was filed earlier on 19 December 2025, has been entered.
Status of the Claims
Applicant amended claim 1 and cancelled claim 27. Claim 1 was cancelled previously by Applicant. Claims 2-26 are pending.
Status of the Rejections and Objections
All rejections set forth in the previous Office action (19 September 2025) are withdrawn.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: “Multiparticulate Budesonide Formulations.”
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 2-26 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 claim 2, if the multiparticulates (cores) are individually coated with the “enteric coating” recited later in the claim, does that enteric coating count toward the earlier-recited “total coated core weight”? 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 claims 8 and 9, both of which recite similarly ambiguous claim limitations.
In further regard to claim 2, how does the functional language recited at the end of claim 2 (i.e., “wherein the pharmaceutical composition is suitable for treating IgA nephropathy”) further define the configuration or compositional profile of the claimed pharmaceutical composition? Applicant is referred to MPEP § 2173.05(g) (“Notwithstanding the permissible instances, 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.”). This ambiguity renders claim 2 and all claims depending thereon indefinite.
Regarding claim 25, it is unclear whether (and, if so, how) the phrase recited therein further limits the claim. How does the number of times the claimed pharmaceutical composition is tested influence its structure?
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 2-26 are rejected under 35 U.S.C. 103 as being unpatentable over Watts (US 8,491,932 B2) alone or in view of Ulmius (US 5,643,602).
Watts 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 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 cured to form a single polymeric phase coating. The examiner’s position is supported by page 44 of Applicant’s specification, as originally filed, which states in relevant part: “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. [0226]. Applicant is reminded that “[d]uring patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’” MPEP § 2111, quoting Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc).
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. Accordingly, the capsules of Watts are considered suitable for treating IgA nephropathy. MPEP § 2111 (quoted above).
As established above, Watts discloses that 4 kg of budesonide cores are coated with 778 g of the extended-release polymeric blend (ethylcellulose/HPMC/PEG). The calculation of 778 g / (778 g + 4,000 g) yields a weight percentage of 16.3%, which seemingly lies inside the concentration range recited in claim 2 of the present application. In the alternative, Ulmius 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. Therefore, claims 2, 8-14, and 25 are prima facie obvious.
Regarding claims 3-4, 20-24 and 26, 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).
Regarding claims 5-7, 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 15-17, 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 18, 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 19, Watts teaches that each capsule of Example 2 comprises 4 mg of budesonide. Column 11, lines 48-50.
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 2-26 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).
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 2-26. 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 2-26 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 December 29, 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 2-26. 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 2-26 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 2-26. 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 2-26 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 2-26. 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 2-26 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.
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/P.A./
31 March 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611