Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments filed 05/03/2026.
Claims 3-7 and 9-12 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant elected Group II in the reply filed on 09/29/2025.
Claims 3-7 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 9-11 are examined on the merits herein.
REJECTIONS—MODIFIED
Applicant’s IDS submission has resulted in the below modified rejection.
The 35 USC 103 rejections in the previous Office Action, over Herbig in view of Wrobleski and Pandi, and Herbing in view of Wrobleski and Pandi, and further in view of Tonglairoum, are hereby withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(New) Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over EP 1027888 to Appel (published 2009, IDS of 05/03/2026) in view of Wrobleski (Highly Selective Inhibition of Tyrosine Kinase 2 (TYK2) for the Treatment of Autoimmune Diseases: Discovery of the Allosteric Inhibitor of BMS-986165, J. Chem, published 2019, PTO-892 of 02/02/2026)
Appel teaches osmotic systems for delivery of solid amorphous dispersions of drugs.
Appel teaches a controlled release dosage form comprising a core comprising an osmotic agent and a drug in the form of a spray-dried solid dispersion of an amorphous drug in a dispersion polymer, wherein the drug has an aqueous solubility of 40 mg/mL or less, and a substantially water permeable coating around the core (pg. 19, claims 1-3; pg. 21, claim 29).
Appel teaches a dosage form wherein the osmotic agent is in a first layer and the solid dispersion is in a second layer (pg. 20, claim 21).
Appel exemplifies a tablet bilayer design, wherein the core comprises a drug layer comprising a solid amorphous dispersion comprising the drug, polyethylene oxide (osmogen & polymer), and HPMC (osmogen & polymer), and wherein the sweller layer comprises polyethylene oxide (osmogen) and HPMC (osmogen). The bilayer core is then coated with a semipermeable coating comprising 50-98% cellulose acetate and 2-50% polyethylene glycol (pg. 15, Example 4, and pg. 13, Example 2 for the drug). See also Example 7 on pg. 17.
Appel differs from that of instant claim 9 in that it does not teach BMS-986165 as the drug.
Appel further teaches the drug as an autoimmune disorder agent (pg. 20, claim 33), and teaches that any beneficial therapeutic agent that meets the solubility criteria can be used as the drug ([0025]).
Appel teaches its dosage forms as specifically designed to provide controlled release by an extrusion-type mechanism of low solubility drug that utilizes a core of such a drug in the form of an amorphous solid dispersion ([0013]). The dosage form provides controlled delivery of the drug and in turn, the bioavailability of the drug is enhanced ([0018]).
Wrobleski teaches BMS-986165, also referenced as “11,” as a small molecule JAK inhibitor that has emerged as a major therapeutic advancement in treating autoimmune diseases, (abstract).
Wrobleski teaches Triazole 11, which is BMS-986165 (see Table 5 on pg. 8980, and the abstract of Wrobleski) as having an aqueous solubility at pH 7.4 of 5.2µg/mL (pg. 8981, Table 7).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the BMS-986165 of Wrobleski as the drug in Appel, to arrive at instant claim 9. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Wrobleski teaches BMS-986165 for the treatment of autoimmune diseases (abstract) and Appel teaches the drug in its formulations as an autoimmune disorder agent,
-Appel teaches its drugs as having an aqueous solubility of 40 mg/mL or less and that any beneficial therapeutic agent that meets the solubility criteria can be used as the drug, and
-Wrobleski teaches BMS-986165 as having an aqueous solubility at pH 7.4 of 5.2µg/mL, which is less than 40 mg/mL.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a dosage form that provides controlled delivery and enhanced bioavailability of BMS-986165.
Regarding claim 10, Appel teaches its bilayer core is as coated with a semipermeable coating comprising 50-98% cellulose acetate and 2-50% polyethylene glycol (pg. 15, Example 4, and pg. 13, Example 2 for the drug).
Regarding claim 11, Appel exemplifies its tablet bilayer core is as coated with a semipermeable coating comprising 50-98% cellulose acetate and 2-50% polyethylene glycol, as discussed above, and teaches that the coating as in an amount ranging from 5-30% of the core weight ([0049]); in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Response to Arguments
The above rejection is new. The arguments directed toward Herbig are not persuasive to overcome the above prior art rejection.
Conclusion
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in on 05/03/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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