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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 11, 13-18, and 20, in the reply filed on 09/02/2026 is acknowledged.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 13 is objected to because of the following informalities: It appears that the claim has invoked a Markush group, it should be amended as follow:” …selected from the group consisting of one or more hydrogenated oils…”
Appropriate correction is required.
Claims 16 and 17 are objected to because of the following informalities: The claim recites the limitation “about” , however an exactitude has not been claimed, but rather a contemplated variation.
Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Allian et al. (US 2022/0073530 A1) and further in view of Guitard et al. (US 2008/0187582 A1) (“Guitard” herein).
Claims 11 & 13.
Allian discloses an extended release solid dosage form comprising [0016, 0599]
a) upadacitnib freebase equivalent; [0096, 0127, 0466]
b) an acidic pH modifier; [0453, 0602--0603] and
c) lubricant [0601-0602]
Allian however does not explicitly disclose the lubricant as a lipophilic release retardant. selected from one or more hydrogenated oils comprising from hydrogenated vegetable oil, cottonseed oil, castor oil, canola oil, palm oil, palm kernel oil and soybean oil, cetostearyl alcohol, cetyl alcohol, glyceryl behenate derivatives, glyceryl mono oleate, glyceryl mono stearates, glyceryl palmito stearates, lecithin, mono-di- and triglycerides with polyethylene glycol (PEG) esters of fatty acid, medium chain triglycerides, carnauba wax, microcrystalline wax, beeswax or any combination thereof.
Guitard teaches the above limitation (See paragraph 0075→ Guitard teaches this limitation in that Lubricants according to the invention include e.g. Mg-, Al- or Ca-stearate, PEG 4000-8000, talc, sodium benzoate, glyceryl mono fatty acid, e.g. having a molecular weight of from 200 to 800 Daltons, e.g. glyceryl monostearate (e.g. Danisco, UK), glyceryl dibehenate (e.g. COMPRITOLAT.TM. 0888, Gattefosse France), glyceryl palmito-stearic ester (e.g. PRECIROL.TM., Gattefosse France), polyoxyethylene glycol (PEG, BASF), hydrogenated cotton seed oil (Lubitrab, Edward Mendell Co Inc) and castor seed oil (Cutina HR, Henkel). Preferably, magnesium stearate is used.) for the purpose of being used for the treatment or prevention of the diseases for which the active agent it contains, is useful such an inflammatory and hyperproliferative skin diseases (such as psoriasis, atopic dermatitis, allergic contact dermatitis, irritant contact dermatitis and further eczematous dermatitises, seborrhoeic dermatitis). [0086]
Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to replace the lubricant of Allian, with the above limitation, as taught by Guitard in order to prevent or treat inflammatory and hyperproliferative skin diseases. [0086]
Since Allian teaches the same composition in a tablet comprising an upadacitnib freebase equivalent; an acidic pH modifier; and a lubricant such as a hydrogenated cotton seed, it would be a an extended release solid dosage form and be a lipophilic release retardant.
"Products of identical chemical composition cannot have mutually exclusive properties”. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and /or claims are necessarily present. See MPEP 2112.01 (I), In re Best, 562 F2d at 1255, 195 USPQ at 433, Titanium Metals Corp v Banner, 778 F2d 775, 227 USPQ 773 (Fed Cir 1985) , In re Ludtke, 441 F2d 660, 169 USPQ 563 (CCPA 1971) and Northam Wareen Corp v DF Newfield Co, 7 F Supp 773, 22 USPQ 313 (EDNY1934).
Claim 12.
The pharmaceutical composition according to claim 1, wherein the composition further contains 5% to 55% of lipophilic release retardant. [0601-0602, Table 6]
Claim 14.
Allian discloses the extended release solid dosage form of claim 12, wherein the lipophilic release retardant is glyceryl behenate derivatives. (Same as claim 11)
Claim 15.
Allian discloses the extended release solid dosage form of claim 13, wherein the organic acid is tartaric acid. [0453, 0602--0603]
Claim 16.
Allian discloses the extended release solid dosage form of claim 12, wherein the extended release formulation provides for the release of upadacitinib upon entry into a use environment at a rate substantially independent of the pH of the use environment, wherein the use environment has a pH range from about 1.2 to about 6.8. [0201, 0571, 0578]
It is elementary that the mere recitation of a newly discovered function or property possessed by things in the prior art, does not cause a claim drawn to distinguish over the prior art. Additionally, where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be a characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. In re Swinehart, 169 USPQ 226 (CCPA 1971).
Claim 17.
Allian discloses the extended release solid dosage form of claim 15, wherein the organic acid is present in an amount from about 10 w/w % to about 35 w/w %. [0453, 0602--0603]
Claim 18.
Allian discloses the extended release solid dosage form of claim 16, wherein the organic acid is tartaric acid. [0453, 0602--0603]
Claim 20.
Allian discloses the extended release solid dosage form of claim 15, wherein the extended release solid dosage form is tablet. [0599]
Claims 11-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Allian et al. (US 2022/0073530 A1) and further in view of Gumudavelli et a. (US 2017/0312226 A1) (“Gumudavelli” herein).
Claims 11 &13.
Allian discloses an extended release solid dosage form comprising [0016, 0599]
a) upadacitnib freebase equivalent; [0096, 0127, 0466]
b) an acidic pH modifier; [0453, 0602--0603] and
c) polymer [0579, 0602]
Allian however does not explicitly disclose the polymer as a lipophilic release retardant. selected from one or more hydrogenated oils comprising from hydrogenated vegetable oil, cottonseed oil, castor oil, canola oil, palm oil, palm kernel oil and soybean oil, cetostearyl alcohol, cetyl alcohol, glyceryl behenate derivatives, glyceryl mono oleate, glyceryl mono stearates, glyceryl palmito stearates, lecithin, mono-di- and triglycerides with polyethylene glycol (PEG) esters of fatty acid, medium chain triglycerides, carnauba wax, microcrystalline wax, beeswax or any combination thereof.
Gumudavelli teaches the above limitation (See paragraph 0039 & 0116→ Gumudavelli teaches this limitation in that the lubrication agents are lipophilic and may belong to a class of fatty acid esters that include glyceride esters, glyceryl monostearate, glyceryl tribehenate, glyceryl dibehenate, and sugar esters, sorbitan monostearate and sucrose monopalmitate, the lubrication agents are metallic salts of fatty acids, magnesium, calcium or zinc salts of stearic acid, mystic acid, palmitic acid, and combinations thereof., and the lubrication agents belong to a class of inorganic materials, talc, calcium silicate. When present within the composition, the fat/wax generally makes up between about 5% to about 40% by weight of the composition, Thus, for example, the fat/wax may make up a larger percentage by weight of the a granulate that uses only a first material and one which includes both, for example, ethylcellulose and HPMC. Fats are fatty acid based compounds generally having a hydrophilic/lipophilic balance (HLB) of about 6 or less and also have a melting point which is preferably 30° C. or more,. Fats, including fatty acids and fatty esters in accordance with the present invention may be substituted or unsubstituted, saturated or unsaturated. However, generally they have a chain length of at least about 14. The esters in question may include fatty acid groups bound to alcohols, glycols, and in particularly preferred embodiment, glycerol. With regard to glyercols, for example, mono-, di-, and tri-fatty substituted glycerols are contemplated as are mixtures thereof. Thixotropic fats/waxes can also be used. Suitable fat ingredients include, without limitation, glycerol fatty esters, fatty glyceride derivatives, waxes and fatty alcohols such as, for example, glycerol behenate (COMPRITOL®), glycerol palmitostearate (PRECIROL®), stearoyl macroglycerides (GELUCIRE®50/13). A particularly preferred material useful in accordance with the present invention is glycerol behenate. Waxes include, without limitation, insect and animal waxes, vegetable waxes, mineral waxes, petroleum waxes, and synthetic waxes. Particularly preferred are beeswax, carnauba wax, condelilla wax, montan wax, ouricury wax, rice-bran wax, jojoba wax, microcrystalline wax, cetyl ester wax, anionic emulsifying wax, nonionic emulsifying wax and paraffin wax. In one embodiment, the fat/wax is a fatty acid ester of glycerol. In another, the fatty acid ester of glycerol is glycerol behenate, glyceryl dibehenate, and/or glyceryl behenate, such as COMPRITOL® 888ATO.) for the purpose of
providing the sustained-release matrix multiparticulate systems, tablets, or capsules can be coated with a sustained release coating such as the sustained release coatings described herein. Such coatings preferably include a sufficient amount of hydrophobic and/or hydrophilic sustained-release material to obtain a weight gain level from about 2 to about 25 percent, although the overcoat may be greater depending upon, e.g., the desired release rate. [0144]
Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify Allian, with the above limitation, as taught by Gumudavelli, in order to provide the desired release rate.
Claim 12.
Allian discloses the pharmaceutical composition according to claim 1. Allian however does not explicitly disclose, wherein the composition further contains 5% to 55% of lipophilic release retardant. (Same as claim 11)
Claim 14.
Allian discloses the extended release solid dosage form of claim 12, wherein the lipophilic release retardant is glyceryl behenate derivatives. (Same as claim 11)
Claim 15.
Allian discloses the extended release solid dosage form of claim 13, wherein the organic acid is tartaric acid. [0453, 0602--0603]
Claim 16.
Allian discloses the extended release solid dosage form of claim 12, wherein the extended release formulation provides for the release of upadacitinib upon entry into a use environment at a rate substantially independent of the pH of the use environment, wherein the use environment has a pH range from about 1.2 to about 6.8. [0201, 0571, 0578]
It is elementary that the mere recitation of a newly discovered function or property possessed by things in the prior art, does not cause a claim drawn to distinguish over the prior art. Additionally, where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be a characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. In re Swinehart, 169 USPQ 226 (CCPA 1971).
Claim 17.
Allian discloses the extended release solid dosage form of claim 15, wherein the organic acid is present in an amount from about 10 w/w % to about 35 w/w %. [0453, 0602--0603]
Claim 18.
Allian discloses the extended release solid dosage form of claim 16, wherein the organic acid is tartaric acid. [0453, 0602--0603]
Claim 20.
Allian discloses the extended release solid dosage form of claim 15, wherein the extended release solid dosage form is tablet. [0599]
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Crowley et al. (US 2008/0020032 A1) HYDROPHOBIC ABUSE DETERRENT DELIVERY SYSTEM FOR HYDROMORPHONE, Merchant et al. (US 2017/0152273 A1) Topical Pharmaceutical Formulation For Treating Inflammatory-related Condition, E.g. Psoriasis Or Atopic Dermatitis, Comprises 5-(4-cyanophenoxy)-1,3-dihydro-1-hydroxy-2,1-benzoxaborole, Propylene Glycol, And Butylated Hydroxytoluene, and Thakkar et al. (US 2019/0046527 A1) METHODS OF TREATING CROHN'S DISEASE AND ULCERATIVE COLITIS.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SILVANA C RUNYAN whose telephone number is (571)270-5415. The examiner can normally be reached M-F 7:30-4:30.
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/SILVANA C RUNYAN/Primary Examiner, Art Unit 1616 09/24/2026
