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 .
Applicant’s election without traverse of Group I (claims 12, 15-19 and 33) in the reply filed on September 3, 2026, and applicant canceled claim 33. Claims 23-29 and 34-37 are withdrawn from further consideration as being drawn to nonelected inventions. In the restriction requirement, the Examiner stated that claims 1-7, 11, 20-22 and 30-32 would be examined together with the elected group. Thus, claims 1-7, 11, 12, 15-22 and 30-32 are being examined in this Office Action.
Applicant need to change the claim status identifiers to --- (withdrawn) --- for the withdrawn claims.
Claim Objections
Claim 5 is objected to because of the following informalities: applicant need to delete “any one or more” on line 2 (the presence of the term makes the meaning of the claim confusing). Appropriate correction is required.
Claim 11 is objected to because of the following informalities: applicant need to change “being any one or more” to ---, wherein the first unit and the second unit are each independently ---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: on line 2, applicant need to change “enteric-coating” to --- enteric-coating base ---. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: applicant need to change “comprise” on line 2 to --- comprises ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 15 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.
It is the Examiner’s understanding that the enteric-coating base is a polymeric material, yet the list for the enteric-coating base in instant claim 15 includes monomeric compounds, e.g., acrylic acid, methacrylic acid, methyl acrylate, ethyl acrylate, methyl methacrylate, ethyl methacrylate. Did applicant mean to claim a polymer or a copolymer made from such monomers instead (if so, applicant need to make appropriate correction)?
Claim 18 contains the trademark/trade name Opadry OY-C-7000A. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a film coating system containing a mixture of 54.85 wt.% HPMC 2910/Hypromellose, 22.86 wt.% titanium dioxide,13.72 wt.% ethyl cellulose and 8.57 wt.% diethyl phthalate (which is a pre-formulated, white dry film coating system manufactured by Colorcon used to coat pharmaceutical tablets and capsules) and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7, 11, 12, 18 and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johansson et al (US 2010/0178334 A1).
Johansson teaches (abstract) a fixed oral dosage form comprising a proton pump inhibitor in combination with acetylsalicylic acid (“ASA”), for use as a medicament for the prevention of thromboembolic vascular events, such as myocardial infarction or stroke, and for the prevention and/or reduction of gastrointestinal complications associated with the use of acetylsalicylic acid.
Specifically, in its Example 4, Johansson teaches a capsule comprising (i) a mixture of enteric coated pellets comprising Esomeprazole-Mg trihydrate (corresponding to 20 mg Esomeprazole) and Mg-Stearate (lubricant – see [0077]); and (ii) ASA tablet comprising 75 mg ASA (the pellets comprising Esomeprazole-Mg trihydrate (corresponding to 20 mg Esomeprazole) teaches instant second unit which is a pellet and the ASA tablet comprising 75 mg ASA teaches instant first unit which is a tablet).
Thus, Johansson teaches instant claims 1-7, 11 and 32 (the claim language of claim 4 does not require that the proton pump inhibitor of claim 3 is rabeprazole, it only requires that if the proton pump inhibitor is rabeprazole, then the rabeprazole has to have a dose of 5-20 mg per unit dosage form).
With respect to instant claims 12 and 18, in Example 4, Johansson states ([0151]) that the enteric coated pellets comprising Esomeprazole-Mg trihydrate (corresponding to 20 mg Esomeprazole) were manufactured and mixed with Mg-Stearate according to its Example 2: in Example 2, Johansson teaches ([0141]-[0144]) that after the core material (“Active Layer”) was prepared, the core material was covered with a subcoating layer containing hydroxypropyl cellulose (instant moisture-proof inner coating base of claim 18) and then sprayed with an enteric coating layer containing methacrylic acid copolymer type C (thus, Johansson teaches instant limitation (C) of claim 12). Thus, Johansson teaches instant claims 12 and 18.
With respect to instant claim 30, as shown above, Johansson’s capsule comprises (i) a mixture of enteric coated pellets comprising Esomeprazole-Mg trihydrate and Mg-Stearate (a lubricant), where the pellets comprising Esomeprazole-Mg trihydrate (corresponding to 20 mg Esomeprazole) teaches instant second unit. In forming the pellets comprising Esomeprazole-Mg trihydrate in Example 2, Johansson further adds excipients (hydroxypropyl methylcellulose and polysorbate 80) to the Esomeprazole-Mg trihydrate (see the table under “Active Layer” in Example 2). Thus, Johansson teaches instant second unit of claim 30 further comprising excipients. Furthermore, the capsule also comprises approximately 97 mg of (ii) ASA tablet comprising 75 mg ASA, which implies the presence of 22 mg of unnamed excipients in the ASA tablet (instant first unit). Therefore, Johansson teaches instant first unit of claim 30 further comprising excipients. Thus, Johansson teaches instant claim 30.
With respect to instant claim 31, Johansson teaches (see claims 26 and 27) that its capsule comprising acetylsalicylic acid and proton pump inhibitor is administered once daily. Thus, Johansson teaches instant claim 31.
Claim Rejections - 35 USC § 103
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.
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) 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al (US 2010/0178334 A1).
With respect to instant claims 15-16, as discussed above, in Johansson’s Example 2, after the core material was prepared, the core material was covered with a subcoating layer containing hydroxypropyl cellulose (instant moisture-proof inner coating base of claim 18) and then sprayed with an enteric coating layer containing methacrylic acid copolymer type C, but Johansson does not explain what “methacrylic acid copolymer type C” is exactly. However, in [0071], Johansson teaches the equivalence of methacrylic acid copolymers and other polymers, which are cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate and shellac, as its enteric coating layer polymers. It would be obvious to one skilled in the art to use one of these other polymers (instead of methacrylic acid copolymer type C) as the enteric coating layer polymer with a reasonable expectation of success. Thus, Johansson renders obvious instant claims 15 and 16.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al (US 2010/0178334 A1) alone, or alternatively, over Johansson et al (US 2010/0178334 A1) in view of Weiss et al (US 2013/0266658 A1).
With respect to instant claim 17, as discussed above, in Johansson’s Example 2, after the core material was prepared, the core material was covered with a subcoating layer containing hydroxypropyl cellulose (instant moisture-proof inner coating base) and then sprayed with an enteric coating layer containing methacrylic acid copolymer type C. Johansson further teaches ([0073]) that the film thickness of the enteric coating can range from 15 to 45 microns and that the maximum thickness for the enteric coating is normally only limited by processing conditions and the desired dissolution profile. Under such guideline given by Johansson, instant range for the content of the enteric-coating (3-15 wt.% relative to instant second unit) would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Alternatively, Weiss teaches ([0016]-[0021]) proton pump inhibitor (PPI) pellets that consist of PPI cores, inert intermediate layer (instant moisture proof inner coating) that coat the cores, and enteric layer that coats the intermediate layer. In Table 2 ([0126]), Weiss gives specific examples of its inventive PPI pellets that have enteric layer amounts (relative to the pellet core containing omeprazole (equivalent to instant second unit)) which range from 3.8 wt.% to 4.8 wt.% (the total weight of the pellet core is 1000g; the lowest amount of the enteric layer is 38.33 g (24.15 + 9.66 + 2.42 + 2.10 = 38.33), which give the lower end for the enteric layer amount (relative to the pellet core) to be 3.8 wt.%; the highest amount of the enteric layer is 47.61 g (35.01 + 7 + 3.5 + 2.1 = 47.61), which gives the higher end for the enteric layer amount (relative to the pellet core) to be 4.8 wt.%). It would have been obvious to one skilled in the art to have the amount of the enteric coating layer in Johansson to range from 3.8 wt.% to 4.8 wt.% (relative to the pellets comprising Esomeprazole-Mg trihydrate (corresponding to 20 mg Esomeprazole) (instant second unit)) with a reasonable expectation of success. Such range falls within instant range of 3-15 wt.% (relative to instant second unit) and thus teaches instant range. Thus, Johansson alone or Johansson in view of Weiss renders obvious instant claim 17.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al (US 2010/0178334 A1) in view of Weiss et al (US 2013/0266658 A1).
With respect to instant claim 19, as discussed above, in Johansson’s Example 2, after the core material was prepared, the core material was covered with a subcoating layer containing hydroxypropyl cellulose (instant moisture-proof inner coating base) and then sprayed with an enteric coating layer containing methacrylic acid copolymer type C. Johansson does not explicitly teach the amount for the subcoating layer (instant moisture-proof inner coating) or its thickness. As discussed above, Weiss teaches proton pump inhibitor (PPI) pellets that consist of PPI cores, inert intermediate layer (equivalent to instant moisture proof inner coating) that coat the cores, and enteric layer that coats the intermediate layer. In Table 2 ([0126]), Weiss gives specific examples of its inventive PPI pellets that have intermediate layer amounts (relative to the pellet core containing omeprazole (equivalent to instant second unit)) which range from 0.87 wt.% to 1.1 wt.% (the total weight of the pellet core is 1000g; the lowest amount of the intermediate layer is 8.7 g (4.35 + 4.35 = 8.7), which gives the lower end for the intermediate layer amount (relative to the pellet core) to be 0.87 wt.%; the highest amount of the intermediate layer is 11.11 g (3.12 + 4.87 + 3.12 = 11.11), which gives the higher end for the intermediate layer amount (relative to the pellet core) to be 1.1 wt.%). It would have been obvious to one skilled in the art to have the amount of the subcoating layer (instant moisture proof inner coating) in Johansson to range from 0.87 wt.% to 1.1 wt.% (relative to the pellets comprising Esomeprazole-Mg trihydrate (corresponding to 20 mg Esomeprazole) (instant second unit)) with a reasonable expectation of success. Such range overlaps with instant range 1-3 wt.% relative to the second unit, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Johansson in view of Weiss renders obvious instant claim 19.
Claim(s) 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al (US 2010/0178334 A1) in view of Movva et al (US 2011/0293713 A1).
As already discussed above, in Example 4, Johansson teaches a capsule comprising (i) a mixture of enteric coated pellets comprising Esomeprazole-Mg trihydrate (corresponding to 20 mg Esomeprazole) and Mg-Stearate (lubricant); and (ii) ASA tablet comprising 75 mg ASA, where the pellets comprising Esomeprazole-Mg trihydrate (corresponding to 20 mg Esomeprazole) teaches instant second unit which is a pellet and the ASA tablet comprising 75 mg ASA teaches instant first unit which is a tablet. Johansson’s pellets comprising Esomeprazole-Mg trihydrate does not include instant basic stabilizer. Movva teaches ([0062]-[0063] and [0009]) using at least one alkaline stabilizer, such as calcium hydroxide, magnesium hydroxide or magnesium oxide, together with esomeprazole magnesium (such as esomeprazole magnesium trihydrate) to minimize degradation of the proton pump inhibitor in acidic environments. It would have been obvious to one skilled in the art to use calcium hydroxide, magnesium hydroxide or magnesium oxide together with Johansson’s Esomeprazole-Mg trihydrate with a reasonable expectation of minimizing degradation of esomeparazole in acidic environments. Thus, Johansson in view of Movva renders obvious instant claims 20 and 21.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al (US 2010/0178334 A1) in view of Movva et al (US 2011/0293713 A1), as applied to claim 21 above, and further in view of Liaoning Victory Fire-retardant Material Technology Co., Ltd (“What is the difference between light magnesium oxide, heavy magnesium oxide, active magnesium oxide and magnesium hydroxide?”, an internet article published on March 25, 2021 and obtained from the website: https://www.vtalc.com/news/what-is-the-difference-between-light-magnesium-oxide-heavy-magnesium-oxide-active-magnesium-oxide-and-magnesium-hydroxide ).
As discussed above, Movva teaches using alkaline stabilizer(s), such as calcium hydroxide, magnesium hydroxide or magnesium oxide, together with esomeprazole magnesium to minimize degradation of the proton pump inhibitor in acidic environments. Movva does not teach that the magnesium oxide has a bulk density of less than 330 g/L. As evidenced by an internet article “What is the difference between light magnesium oxide, heavy magnesium oxide, active magnesium oxide and magnesium hydroxide?” by Liaoning Victory Fire-retardant Material Technology Co., Ltd (“Liaoning Victory”) (see the 1st two paragraphs under “Industrial magnesium oxide”), it is known in the art that industrial magnesium oxide (used in medicine as an antacid) has a bulk density between 0.2 and 0.3 g/mL, which converts to 200-300 g/L. Thus, it would be obvious to one skilled in the art to use industrial magnesium oxide having a bulk density of 200-300 g/L as the magnesium oxide as the alkaline stabilizer (antacid) together with Johansson’s Esomeprazole-Mg trihydrate with a reasonable expectation of minimizing degradation of esomeparazole in acidic environments. Thus, Johansson in view of Movva, and further in view of Liaoning Victory renders obvious instant claim 22.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
September 28, 2026
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