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 .
Priority
Foreign priority to application CN202311295239.1 filed 10/09/2023 is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on 09/15/2026 is acknowledged.
Claims 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/15/2026.
Claims 1-7 are pending and under current examination.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. Specifically, abstract should not reference trademarked products, such as Xeljanz® (line 10).
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The use of the term Xeljanz® (instant specification pg. 1 lines 19 and 21), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
While the concentrations of the components in instant claim 1 are recited in parts by weight, they can be converted into wt.% to allow for comparison between concentrations in prior art, using the following general formulas (where A, B, C, represent different components in the formulation).
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Of the substances that make up the weight of the core tablet (i.e. tablet without the weight of the sustained-release coating), the tofacitinib citrate makes up 14.2-21.3 wt.%, the diluent makes up 42.8-62.8 wt.%, the binder makes up 8.7-21.4 wt.%, the matrix makes up 8.7-21.4 wt.%, glidant 0.2-0.9 wt.%, and the lubricant 0.4-1.8 wt.%. For the total weight of the tablet, the sustained-release coating makes up 9.3-24.1 wt.%, as recited in instant claim 1, and 11.3-23.0%, for the range recited in instant claim 5.
Regarding the components of the sustained-release coating, using the parts by weight of instant claim 6 to convert to wt.%, the hypromellose makes up 46.5-84.5 wt.% of the coating, the plasticizer 0.99-10.7 wt.%, and the mineral hydrophobic material 13.2-49.4 wt.%.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 3 and 4, the recitation of povidone K29/32, hydroxypropyl cellulose LF, hypromellose K100LV, hypromellose K4M, hydroxypropyl cellulose GXF, hydroxypropyl cellulose EXF, and carbomer 971P NF are not proper. The compounds should be listed as their generic chemical names with viscosities and molecular weights provided. The use of the industrial suffix codes which can change over time to represent viscosities or molecular weights is improper.
Claim Rejections - 35 USC § 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 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.
Claim(s) 1, 2, 4, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Herbig (CA 2905604 A1) in view of Yin (CN110787145A; see machine translation retrieved 10/01/2026) and Li (WO2022262802; see machine translation retrieved 10/01/2026), in further view of Long (CN 107595795 A; see machine translation retrieved 10/02/2026), as evidenced by Brown et al. (Macromolecules, 1986, 19, 1255-1260), hereinafter Brown.
Regarding claims 1, 4, and 5, Herbig teaches an oral sustained release formulation of tofacitinib and pharmaceutical acceptable salts (i.e. tofacitinib citrate, pg. 2 line 13), where the formulations have desirable pharmacokinetic characteristics (see abstract). Herbig describes an example of a formulation where the tofacitinib citrate makes up 17.828 wt.% of the core tablet, the binder 6 wt.%, the glidant 1 wt.%, and the lubricant 1 wt.% (see Table 6). The concentrations of the tofacitinib citrate and lubricant of instant claim 1 overlap with those disclosed in Herbig, and as such are obvious. While the glidant of instant claim 1 is 0.9 wt.%, and 1 wt.% in Herbig, a prima facie case of obviousness still exists. See MPEP § 2144.05(I) ("The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”) Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Herbig further teaches that the coating can be modified by plasticizers that are known in the art (pg. 57 line 16), and the coating comprises polyethylene glycol (see Table 17) and talc (pg. 47 line 6). The preferred HPMC (i.e. hypromellose) of Herbig has a viscosity of 80-120 cp, and is HPMC K100LV (pg. 15, lines 6-7). The viscosity of the hypromellose of instant claim 1 overlaps with that described in Herbig, and as such is obvious. MPEP § 2144.05(I).
While Herbig teaches most components of instant claim 1, it fails to teach the concentrations of the diluent and matrix material that make up the tablet core. Yin teaches a sustained-release formulation of tofacitinib citrate, where the tablet core comprises 2-20 wt.% of tofacitinib citrate 20-50 wt.% matrix material, 40-80 wt.% diluent, and 0.1-3 wt.% lubricant (see claim 1). Yin further describes that the sustained-release coating makes up 1-15 wt.% of the tablet core weight (see claim 1). The concentrations of the tofacitinib citrate, matrix material, diluent, lubricant, and coating recited in instant claims 1 and 5 overlap with that of Yin, and as such are obvious. The coating of the composition of Yin further comprises talc powder or kaolin (see claim 7). Yin teaches that the sustained-release coating contains a pore-forming agent (see abstract), which is later described to be made up of hydroxypropyl methylcellulose (i.e. hypromellose, para. [0018]).
Herbig and Yin are considered to be analogous to the claimed invention because they are in the same field of sustained-release tablets comprising tofacitinib citrate. One of ordinary skill in the art would be motivated to optimize the concentrations of the substances in the tablet core and coating of Herbig to have concentrations that fall within the ranges described in Yin, as Yin describes a formulation containing tofacitinib citrate that has effective concentrations for the purpose of sustained release and administration of an active agent. MPEP § 2143(I)(g).
While Herbig and Yin teach the claimed invention as above, they fail to teach the concentration of the binder in the tablet core, and the particle size of the talc powder in the coating, as recited in instant claim 1. Li teaches a sustained-release formulation of tofacitinib, characterized in that it has a tablet core and a sustained-release coating film (see claim 1). Li describes that the coating film includes plasticizers, and talc powder or kaolin (see claim 7), and teaches that the adhesive (i.e. binder) is present in the core at an amount of 1-10 wt.% (para. [0015]). The amount of the binder recited in instant claim 1 overlaps with that of Li, and as such is obvious. MPEP § 2144.05(I). Long teaches a sustained-release tablet comprising a coating material that comprises an anti-adhesion agent that is preferably talcum powder (para. [0038]). Long further describes that the talcum powder has a granularity of 500-2000 meshes (see claim 6), overlapping with the range disclosed in instant claim 1. MPEP § 2144.05(I).
Herbig, Yin, Li, and Long are considered to be analogous to the claimed invention because they are in the same field of sustained-release tablets with a core comprising the active agent, and an outer coating. One of ordinary skill in the art would be motivated to optimize the concentration of the binder in the tablet core of Herbig to fall within the range taught in Yin, since Yin describes a formulation for sustained-release of tofacitinib citrate that has effective concentrations of each component. MPEP § 2143(I)(g). Long teaches a coating that has anti-adhesion components, such as talc powder. As such, one of ordinary skill in the art would be motivated to utilize the talc powder of Long with a particle size of 500-2,000 meshes in the coating of Herbig which also comprises talc, as Long describes these sized particles to be effective for anti-sticking. MPEP § 2143(I)(g).
Regarding claim 2, Herbig describes that diluents of the formulation include lactose, mannitol, and microcrystalline cellulose, as is known in the art (pg. 47, lines 30-31).
Regarding claim 7, Herbig teaches that the polyethylene glycol (PEG) of the coating material is PEG-3350 (see Table 17). Brown teaches a variety of polymer numbers and weight-average molecular weights determined by LD-FTMS, stating that PEG-3350 has a weight-average molecular weight of 3,189 (see Table I). As such, the polyethylene glycol of Herbig has a weight-average molecular weight falling within the range described in instant claim 7.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Herbig (CA 2905604 A1) in view of Yin (CN110787145A), Li (WO2022262802), Long (CN 107595795 A), in further view of Cherukuri (WO 2009140527 A1).
While Herbig, Yin, Li, and Long teach the claimed invention as above, and Herbig teaches that the binder can include hydroxypropyl cellulose and povidone (pg. 47 line 28), they fail to teach that the binder is specifically povidone K29/32 or hydroxypropyl cellulose LF.
Regarding claim 3, Cherukuri teaches an extended release tablet composition for oral administration disclosing that the binder comprises povidone K29/32 (see claim 27).
Herig, Yin, Li, Long, and Cherukuri are considered to be analogous to the claimed invention because they are in the same field of pharmaceutical formulations for extended release. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the povidone binder of Herbig with specifically the povidone K29/32 binder of Cherukuri. Both components are known in the art to function as binders, and both are used in pharmaceutical formulations. Simple substitution of one binder with another is within the purview of the skilled artisan, and would yield predictable results. MPEP § 2143(I)(b).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Herbig (CA 2905604 A1) in view of Yin (CN110787145A), Li (WO2022262802), Long (CN 107595795 A), in further view of Chen (CN 116236463 A; see machine translation retrieved 10/05/2026).
Regarding claim 6, Li teaches that the polyethylene glycol can make up 1-10 wt.% of the sustained-release coating film (see claim 8 and para. [0021]). Li describes that the sustained-release coating has a pore-forming agent (see abstract) which is a polymer such as hydroxypropyl methylcellulose, and makes up 20-50 wt.% of the coating (para. [0018]). One of ordinary skill in the art would be motivated to substitute the concentration of the polyethylene glycol and hydroxypropyl methylcellulose in the coating of Li into the formulation of Herbig, because these concentrations are described to be effective in the composition of Li. MPEP § 2143(I)(b).
While Herbig, Yin, Li, and Long teach the claimed invention as above, they fail to teach the concentration of the mineral hydrophobic material as recited in instant claim 6. Long teaches that talc powder acts as an anti-sticking agent in sustained release tablets (para. [0018]). Chen teaches a sustained release capsule formulation, where the coating that allows the slow release is made up of 8-15 wt.% plasticizer and 20-46 wt.% anti-sticking agent (see claim 1). The concentration of the mineral hydrophobic material of instant claim 6 overlaps with that of Chen, and as such is obvious.
Herbig, Yin, Li, Long, and Chen are considered to be analogous to the claimed invention because they are in the same field of coated tablet formulations that allow for sustained release. The concentrations of the components that make up a sustained-release coating is an optimizable parameter, inviting one of ordinary skill in the art to experiment. One of ordinary skill in the art would be motivated to substitute the concentration of the talc powder in the coating of Herbig, with the concentration of the anti-sticking agent disclosed in Chen, as Chen describes a coating composition that has concentrations effective for sustained-release formulations. MPEP § 2143(I)(b).
Conclusion
Claims 1-7 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
