DETAILED ACTION
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/Restriction
Inventor’s election, without traverse, of the claims of Group I as the group elected to begin prosecution is acknowledged. The election/restriction is hereby made FINAL.
Claim Objections
Applicant is advised that should claim 110 be found allowable, claim 113 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim 121 is 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.
There is insufficient antecedent basis for the limitation “…the second coating comprises 5-30% (wt%) of triethyl citrate…” in the claim. Claim 120, the claim from which claim 121 immediately depends, teaches that, combined, the amount of polysorbate and triethyl citrate in the second coating are only 0.5-4% (wt%).
Clarification is in order.
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.
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.
Claims 103-109 and 111 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0231784 A1, cited in the IDS.
Inventor claims a capsule oral dosage form comprising a therapeutic agent wherein the capsule is coated with a first coating comprising polyvinyl alcohol and a second coating, on top of the first coating, comprising a methacrylic acid and ethyl acrylate copolymer dispersion (independent claim 103). Dependent claim 104 teaches a methacrylic acid/ethyl acrylate ratio in the copolymer of 1.4:1 to 1:1.4. Dependent claim 105 teaches that the polyvinyl alcohol is partially hydrolyzed. Dependent claim 106 teaches that the average molecular weight of the polyvinyl alcohol is 20,000-35,000 Da. Dependent claim 107 teaches that the average molecular weight of the methacrylic acid/ethyl acrylate copolymer is 30,000-40,000 Da. Dependent claim 108 teaches that a third coating, on top of the second coating, is talc. Dependent claim 109 teaches that the capsule consists of gelatin or HPMC. Dependent claim 111 teaches that the second coating does not comprise sodium bicarbonate or titanium dioxide.
US 2019/0231784 A1 teaches an oral solid dosage form comprising a core comprising Compound (I) (which is a BTK inhibitor, i.e. a therapeutic agent) with a first coating comprising a polyvinyl alcohol, and/or hydroxypropyl methyl cellulose, and a second coating, an enteric coating on top of the first coating, comprising at least one polymer selected from an acrylic/methacrylic/ethacrylic acid homopolymer and copolymers thereof, a cellulose derivative and polyvinylpyrrolidone (abstract).
The oral dosage form is explicitly taught to be a tablet or capsule (page 13, [0157]).
Eight tablet formulations comprising a first coating comprising Opadry® II yellow and a second coating comprising Eudragit® L30 D55 are exemplified (Tables 1 and 2 beginning at page 17). Opadry® II yellow is a commercially available pigmented, water soluble, pH independent dry powder film coating formulation comprising polyvinyl alcohol polymer, plasticizer and pigment (which allows for immediate disintegration and fast release) (page 5, [0065]). Eudragit® L30 D55 is a commercially available enteric coating formulation which is a 30% aqueous dispersion of a 1:1 copolymer of methacrylic acid and ethyl acrylate having a molar mass of approximately 320,000 g/mol (i.e. 320,000 Da) (page 5, [0066]).
Inventor principally distinguishes over the exemplified formulations of the cited art in that a capsule is explicitly claimed. However, one of ordinary skill, before the effective filing date of the instant invention, would have found the coating of a capsule, as opposed to the exemplified tablet, obvious, given the explicit teachings of the cited art that either tablets or capsules may be so coated. One of ordinary skill would have been motivated to coat a capsule, guided by ordinary clinical and/or marketing considerations (physician or patient preference, etc.; ease or cost of manufacture, etc.), and with a reasonable expectation of success, given that the cited art explicitly teaches that a capsule may be so coated, in order to provide an alternative oral dosage form.
Claims 105-107 are included in this rejection because the molecular weight of the polymers, and the degree of hydrolysis of the polyvinyl alcohol, are results-effective variables (because the properties of the coatings may be tailored by adjusting the molecular weights of polymers of which they are comprised, and likewise the degree of hydrolysis of the polyvinyl alcohol). While the cited art utilizes commercially available products for the respective first and second coats in the exemplified coating formulations, these commercial products are simply one choice among may possible polyvinyl alcohol (first coat) and methacrylic acid/ethyl acrylate copolymer (second coat) formulations. One of ordinary skill, a highly skilled individual, before the effective filing date of the instant invention and with a reasonable expectation of success, would have found it obvious to tailor the properties of the polymers (e.g. molecular weight, degree of hydrolysis) which make up the coatings in order to further tailor the release profile of the encapsulated drug.
Claim 108 is included in this rejection because a talc coating is simply a ubiquitous anti-tacking formulation, absent unexpected results, utilized in the pharmaceutical industry to facilitate processing/handling of oral tablet, capsule, etc. forms.
Claim 109 is included in this rejection because gelatin and HPMC are, absent unexpected results, simply ubiquitous conventional capsule shell materials.
Allowable Subject Matter
Claims 110, 112-118 and 120 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The subject matter of claim 121 would be allowable once the 112 rejection outlined above has been overcome. The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art appears to be US 2019/02331784 A1 cited above. The cited art does not teach, show, suggest or make obvious the instant capsule oral dosage coated formulations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 9/30/2026
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